17 Financial Regulations jobs in Saudi Arabia

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

Job Description Summary

Job Description

Major Accountabilities

• New Product Registrations - With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products - With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the DRA manager/Head).
• Coordinate with DRA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain, with supervision, the internal DRA database accurate and updated: Dragon/DASA
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with third-party vendors.
• With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
• With Supervision, ensure full support to Global regulatory compliance initiatives in Saudi.

Minimum Requirements

• Pharmacy or related science degree.
• Minimum 1 year of RA Experience in reputable pharmaceutical company.
• Experience handling a portfolio/product and dealing with stakeholder such as SFDA and governmental agency.
• Must be Saudi national.

Skills Desired

Specialist, Regulatory Affairs page is loaded Specialist, Regulatory Affairs Apply locations SA Riyadh time type Full time posted on Posted 8 Days Ago job requisition id JR1999 ARA-P1-10

Responsible for dossier compilation and submission • Responsible for ensuring compliant life cycle management in compliance with market regulations • Manage local Labeling and AWs creation and submission • Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP, • Manage Communication with regulatory agencies or related interface

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:

RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum 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 & rest of ME markets

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. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . 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

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 with Computer based information systems, and new

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.

Company Industry

• Pharma
• Biotech
• Clinical Research

Department / Functional Area

• Administration

Keywords

• Regulatory Affairs Specialist KSA

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We look for people who focus on results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about making a meaningful impact for consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs now and in the future. We embrace diversity and respect the dignity, privacy, and personal rights of every employee.

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Location: KSA, Riyadh

The RA Specialist will manage local regulatory activities to ensure compliance for KSA (70%) and UAE (30%). They will support the RA manager in operational submissions, ensure compliance with all RA and SO responsibilities, and be prepared for audits by HA. The role includes ensuring business continuity, serving as a backup for the RA manager in KSA, and supporting QA and PV functions. The specialist will provide strategic and operational support for product renewals, maintenance, and variations, maintaining momentum to comply with SFDA guidelines.

• Manage registration processes for new products and amendments
• Develop and execute registration strategies in collaboration with Global and local RA teams
• Ensure compliance with evolving regulatory frameworks in KSA and UAE
• Maintain existing product licenses
• Support high-quality and timely submissions; enhance regulatory intelligence; maintain databases for record retention and submission tracking
• Communicate application progress to stakeholders
• Manage regulatory files and documentation; support process improvements and internalize outsourced activities

• Pharmacist or Pharmaceutical Sciences degree
• Saudi MOH license and Saudi nationality
• 4-5 years' experience in regulatory affairs related to medicinal products and medical devices in Saudi Arabia & UAE
• Strong understanding of the pharmaceutical industry and SFDA connections preferred
• Knowledge of Pharmacovigilance and quality systems preferred
• Computer literacy and familiarity with electronic documentation systems
• Fluent in English and Arabic, both written and verbal

• Inclusive work environment embracing diversity
• Competitive compensation, bonus, and benefits
• Growth opportunities with ownership from day one

• Apply with an English CV
• If shortlisted, participate in virtual interviews with recruiter, hiring manager, and team panels

• Seniority level: Mid-Senior
• Employment type: Full-time
• Job function: Legal
• Industry: Pharmaceutical Manufacturing

The Director – Airport Regulatory Affairs is responsible for leading the development, implementation, and oversight of regulatory strategies and compliance frameworks that align with national and international aviation standards. This role acts as the primary interface with civil aviation authorities, government bodies, and international regulatory agencies , ensuring the airport operates in full compliance while shaping and influencing policy that supports long-term strategic objectives.

Key Responsibilities:

Regulatory Strategy & Compliance

• Develop and implement a comprehensive regulatory affairs strategy aligned with the airport’s long-term vision and growth plans.
• Monitor and interpret existing and emerging aviation laws, regulations, and policies (ICAO, IATA, national civil aviation regulations).
• Ensure ongoing compliance with airside, landside, environmental, safety, and security regulations applicable to airport operations and infrastructure.

Stakeholder Engagement & Representation

• Serve as the lead liaison with regulatory bodies, including the Civil Aviation Authority , Ministry of Transport , environmental agencies, customs, and border control.
• Represent the airport in regulatory hearings, consultations, and industry working groups , both domestically and internationally.
• Build strategic alliances and influence regulatory policy to support airport development and innovation.
• Work with the Strategy division to evaluate regulatory risks and opportunities that may impact current or future airport projects.
• Draft formal policy positions, white papers, and briefing notes to support regulatory engagement or lobby for favorable regulatory changes.
• Lead internal alignment on regulatory requirements during project planning , including master planning, airspace design, and sustainability initiatives.

Licensing, Permits & Approvals

• Oversee the licensing and certification process for the airport and key facilities in collaboration with operational units.
• Ensure all necessary permits, certifications, and regulatory submissions are obtained and renewed in a timely manner.
• Establish internal governance frameworks and reporting structures to monitor compliance with aviation and regulatory policies.
• Provide regular updates and risk assessments to the executive leadership team on regulatory developments.
• Prepare board-level reports and strategy input related to regulatory affairs.
• Work with legal, operations, environment, safety, security, and planning teams to integrate regulatory requirements into all aspects of airport development and operations.
• Ensure alignment with ESG , sustainability, and resilience frameworks from a regulatory standpoint.

Qualifications & Experience:

• Bachelor’s degree in Law, Public Policy, Aviation Management, Engineering , or related field
• Master’s degree (e.g., LLM, MPA, MBA, or MSc in Aviation ) is strongly preferred
• Minimum 8 years of experience in aviation regulatory affairs, public policy, legal compliance , or related fields
• At least 3 years in a senior leadership or advisory capacity
• Proven experience engaging with civil aviation regulators, international agencies (ICAO, IATA) , and government institutions
• Prior involvement in airport development, certification, or expansion programs is a strong advantage

• Seniority level Director

• Employment type Full-time

• Job function Other
• Industries Airlines and Aviation

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Specialist, Quality & Regulatory Affairs

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions to help our customers provide cost-efficient, effective healthcare. Join our team of 50,000 partners striving daily to improve healthcare efficiency, support providers, and promote patient health.

We are recruiting a Specialist, Quality & Regulatory Affairs based in Riyadh, Saudi Arabia. Reporting to the Quality and Regulatory Affairs Manager, your responsibilities include:

• Ensuring accurate and timely registration of products with authorities in KSA and other EMEA markets.
• Providing support for Quality & Regulatory Affairs in compliance with applicable regulations to facilitate product commercialization.
• Developing and executing registration strategies in collaboration with Global and local RA managers.
• Supporting regional distribution control to ensure compliance and timely product release.
• Reviewing and validating regulatory data for outbound flow.
• Managing regulatory documentation for new projects.
• Supporting the EMEA QRA team to ensure compliance with national and European regulations.
• Representing QRA in regional project meetings.

Essential Functions and Responsibilities

Under moderate supervision, you will:

• Develop and implement regulatory strategies for product commercialization.
• Prepare documentation for product registration and modifications.
• Coordinate registration activities across EMEA countries.
• Provide regulatory intelligence and support communication with local agents and distributors.
• Act as the QRA representative in project activities.
• Monitor local regulatory environments and provide feedback on new regulations.

Additional responsibilities include:

• Follow-up and improve distribution control procedures.
• Maintain and archive regulatory documentation.
• Support reporting of Serious Adverse Events to authorities.
• Ensure compliance with applicable laws and regulations.
• Communicate issues and opportunities to management.
• Ensure personal and company compliance with policies.
• Train and deploy tools related to distribution control.
• Complete QRA administrative tasks and perform other duties as assigned.

Qualifications and Experience

• BA/BS in a scientific discipline or equivalent experience (minimum 3 years).
• Degree in Pharmacy, Medicine, or Biological sciences preferred.
• At least 3 years' experience in Regulatory Affairs in Saudi Arabia and MEA region.
• Fluent in English and Arabic, both written and verbal.
• Knowledge of SFDA regulations for Medical Devices and strong connections with SFDA are preferred.
• Proficient with MS Office.
• Excellent communication, project management, problem-solving, and presentation skills.
• Proactive, detail-oriented, and able to manage complexity within a matrix organization.
• Comfortable in an international environment with a hands-on attitude.

Benefits

• Comprehensive medical insurance for employee and family.
• Various allowances and long-term disability support.

The Company

Headquartered in Dublin, Ohio, Cardinal Health is a healthcare services company that improves healthcare cost-effectiveness. We support pharmacies, hospitals, and care sites, providing pharmaceuticals and medical products daily to over 100,000 locations. Ranked on the Fortune 500, we employ over 50,000 people worldwide.

We encourage applications from back-to-work individuals, people with disabilities, veterans, and those without a college degree.

Cardinal Health values diversity and is an Equal Opportunity/Affirmative Action employer. All qualified applicants will be considered without regard to race, religion, or other protected statuses.