60 Regulatory Affairs Specialist jobs in Saudi Arabia

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Riyadh, Saudi Arabia

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)

Location: Riyadh

Contract: full-time

Purpose:

The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You will be responsible for:

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements:

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

California Greens Corp. is a leading pharmaceutical and nutraceutical manufacturer with headquarters in New Jersey, USA, and a state-of-the-art production facility in Sudair City for Industry and Businesses, Saudi Arabia. We are committed to delivering high-quality products across the MENA region.

About the Job:

• Job Title : Regulatory Affairs Specialist

• Job Location : Riyadh, Saudi Arabia

• Working hours : Full time

• Benefits : Attractive package based on experience/ Medical insurance

• Application duration: Till 07 / 08 / 2025

Job Responsibilities

• Lead and manage all Regulatory Affairs activities in Saudi Arabia and the MENA region.

• Coordinate product registration processes in collaboration with local agents and regulatory authorities.

• Liaise with the Saudi Food and Drug Authority (SFDA) and other regional regulatory bodies to monitor, follow up, and expedite product (SKU) registrations.

• Respond to regulatory inquiries and ensure the timely resolution of any issues raised by authorities.

• Prepare, review, and submit regulatory dossiers and documentation in full compliance with local and regional requirements.

Required Qualifications

• Bachelor's degree in a scientific or medical field (Pharmacy, Chemistry, Biology).

• Minimum of 3 years of hands-on experience in Regulatory Affairs, specifically with SFDA) within the pharmaceutical or nutraceutical sector.

• Strong understanding and practical knowledge of SFDA, GCC, and MENA regulatory frameworks and guidelines.

• Proficiency in Microsoft Office Suite and regulatory submission platforms.

Personal Skills

• Fluency in both English and Arabic (written and spoken) is essential.

• Teamwork spirit

• Time management

• Problem solving

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Regulatory Affairs Group

Job Sub Function
Regulatory Product Submissions and Registration

Job Category
Professional

All Job Posting Locations:
Riyadh, Saudi Arabia

Job Description
About MedTech
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)
Location: Riyadh
Contract: full-time
Purpose
The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You Will Be Responsible For

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

Life Unlimited.
At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The
Regulatory Affairs Specialist
is responsible for ensuring timely product registration and sustained regulatory compliance across the MENA region, with a focus on Saudi Arabia. This role supports business continuity by securing licenses, handling regulatory submissions, and maintaining positive relationships with local health authorities.

What will you be doing?

• Secure timely registration of new products in accordance with strategic plans.
• Ensure uninterrupted market access through proactive license renewals and tender documentation support.
• Monitor and interpret new and existing regulations, ensuring business alignment and readiness.
• Manage post-market regulatory activities and documentation to uphold compliance.
• Identify and mitigate regulatory risks impacting product lifecycle or market access.
• Maintain positive relationships with health authorities and regulatory bodies across the region.
• Collaborate cross-functionally with Global RA, distributors, and commercial teams to streamline regulatory processes.
• Support regulatory activities for import permits and tender submissions.
• Maintain and update central regulatory databases and product information systems.
• Contribute to the development of regional regulatory strategies in alignment with global objectives.

What will you need to be successful?

• Bachelor's degree in Biomedical Engineering, Pharmacy, or a related
• Saudi Arabian nationality
• Minimum 1 year of experience in regulatory affairs for medical devices.
• Consistent track record in regulatory submissions and compliance with regional health authority requirements.
• In-depth knowledge of SFDA regulations and MENA regional requirements.
• Familiarity with Quality Management System requirements in accordance with ISO 13485 and Good Distribution Practice (GDP).
• Strong understanding of post-market surveillance obligations.
• Experience with product registration and documentation for the KSA market.
• Proficient in English (written and spoken)

You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion and Belonging:
committed to welcoming, celebrating and thriving on diversity, learn more about our Employee Inclusion Groups on our website

Your Future:
annual bonus, company stock saving plan

Work/Life Balance:
paid volunteering hours, flexible approach

Your Wellbeing:
Employee Assistance Program

Flexibility:
possibility of working in hybrid model

Training:
Hands-On, Team-Customized

Extra Perks:
referral bonus, recognition program, mentoring program

Stay connected by joining our Talent Community.

We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day.

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You. Unlimited.
, life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer.

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities
Life-Cycle
management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other Related Tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements
Educational
qualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal Characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

About the Role

Support the registration, maintenance, and compliance of pharmaceutical products with the SFDA and regional health authorities—driving timely submissions, approvals, and adherence to all regulatory requirements.

Key Responsibilities

• Manage product registrations, renewals, variations, and pricing submissions to SFDA and GCC authorities.
• Serve as the primary liaison with SFDA for Scientific Office and Regulatory Affairs communications, including handling and closing authority queries.
• Oversee market maintenance obligations, such as shortage notifications and related compliance requirements.
• Ensure compliance of both promotional and non-promotional activities (materials, events, digital content) with SFDA regulations.
• Coordinate with QA, Medical, Marketing, and Supply Chain teams to collect documentation, support submissions, and maintain accurate records and archives.
• Monitor regulatory updates and translate them into practical internal actions (e.g., SOPs, templates, brief trainings).

Qualifications

• BSc Pharmacy / PharmD
• 1–3 years of Regulatory Affairs experience in the Saudi market; export market exposure is a plus.
• Familiarity with Scientific Office obligations and SFDA e-services; working knowledge of eCTD/RIM is an advantage.
• Strong organization, attention to detail, and stakeholder communication (Arabic & English).

Regards,

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

.

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities

Life-Cycle management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other related tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements

Educationalqualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our colleagues with the resources needed to achieve career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our PPD part of Thermo Fisher Scientific team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our Clinical Operations professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Serves as a senior contact within the Middle East Clinical Operations at CRG, Thermo Fisher Scientific, providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization, ensuring compliance with regulatory bodies in the middle east. Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Acts as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.

• Prepares and reviews regulatory submissions.
• Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
• Leads the development and implementation of project-specific processes for sponsors.
• Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
• Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Provides training and guidance to junior team members as appropriate.
• Participates in project launch meetings, review meetings and project team meetings.
• Supports business development activities, including project budgeting/forecasting

Mandatory requirements

• Saudi Arabia National
• Native Arabic speaker
• Willingness to be based in Riyadh

Knowledge, Skills, Abilities

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Strong English language (written and oral) communication skills as well as local language where applicable
• Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Solid understanding of medical terminology, statistical concepts, and guidelines
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Solid attention to detail and quality as well as strong editorial/proofreading skills
• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Solid negotiation skills
• Strong analytical, investigative and problem-solving skills
• Working knowledge of budgeting and forecasting"

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Regulatory Affairs Specialist KSA
KSA, Riyadh
Job Description
RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and UAE ( 30%) . He / she will support RA manager on operational RA submissions , support RA manager on to ensure compliance of all RA & SO repsonsibilites at all times and to be ready for audits anytime by HA . RA Specialist will ensure business continuity , and serve as a back up for RA manager in KSA for RA in additon to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site including during vacations necessitating the need to have at least 1 RA/ QA/ PV to be available on site all the time .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new prodcuts for Prescription, Injectible aeshetics / Medical devices, Cosmetics . It is critical to maintain mometum to ensure compliance to constantly evolving SFDA guidelines

Duties & Responsibilities

• Manage the entire registration process in ensuring approvals of new products and amendments to products
• Develop and execute registration strategy in close partnership with Global RA & local RA manager
• Stay abreast of - and ensure compliance with - the continuously evolving (complex & country specific) regulatory framework in KSA & UAE
• Ensure compliance with, and maintenance of, existing product licenses.
• Ensure high quality and timely submissions, support in enhancing regulatory intelligence & create & maintain database for simplifying local RA processes of record retention & regulatory submission tracking
• Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate
• Manage in-house regulatory files, documentation and Corporate electronic databases. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner

Minimum Requirements

• Pharmacist degree/Bachelor degree in Pharmaceutical sciences.
• Saudi Arabia national and MOH licensed pharmacist
• Minimum 4-5 years' experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE
• In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred
• Quality experience & fair knowledge of Pharmacovigilance preferred.
• Computer literate, familiar wit
• Manage the entire registration process in ensuring approvals of new products and amendments to products
• Electronic documentation systems.
• Fluency in written and verbal English and Arabic

What We Offer In Return

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
• You will receive a competitive compensation package with bonus structure and extended benefit package.
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.

Next Step

• Please apply with an English language CV.
• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation with the extended team.