What Jobs are available for Regulatory Affairs Manager in Saudi Arabia?

Company Description

Banyan Animal Health is a leading provider of veterinary solutions and services for the poultry and livestock sectors across the Middle East and Africa. With over 20 years of experience, we combine deep regional expertise with a passion for innovation and strong scientific knowledge to empower our partners for growth and optimization. Our commitment to "One Health" drives our efforts, helping farms, production, and businesses thrive. From our base in the Heart of the MEA Region, we create profound and lasting partnerships to equip our partners with tools and knowledge for future challenges.

Role Description

This is a full-time hybrid role for a Registration and Regulatory Affairs Manager with veterinary experience,
flexibly
located in Egypt, Saudi Arabia, UAE and or Jordan
. The Registration and Regulatory Affairs Manager will be responsible for managing regulatory compliance, preparing regulatory submissions, ensuring adherence to regulatory requirements, and maintaining quality systems. The role involves overseeing veterinary regulatory affairs, working closely with both internal and external stakeholders to navigate the regulatory landscape effectively.

Qualifications

• Experience in managing Regulatory Compliance and Regulatory Requirements
• Proven expertise in Regulatory Affairs and Regulatory Submissions
• Ability to maintain and manage Quality Systems
• Strong understanding of veterinary regulations and standards
• Excellent written and verbal communication skills
• Ability to work both independently and collaboratively in a hybrid work environment
• Bachelor's degree in veterinary science, Animal Health, or related field
• Prior experience in the veterinary or animal health industry is a must

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

Key Accountabilities

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.
• Manage communication with SFDA authorities for product approvals and renewals.
• Track and interpret new regulations impacting medical device compliance.
• Maintain product registration database and ensure documentation accuracy.
• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

Knowledge, Skills, And Experience

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Science.
• 8+ years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.
• Strong documentation and submission management skills.
• Excellent English communication.

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.
• Manage communication with SFDA authorities for product approvals and renewals.
• Track and interpret new regulations impacting medical device compliance.
• Maintain product registration database and ensure documentation accuracy.
• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Science.
• 8+ years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.
• Strong documentation and submission management skills.
• Excellent English communication.

Job Scope

Regulatory Affairs Manager to oversee and manage all regulatory activities for pharmaceutical products in the Kingdom of Saudi Arabia. The role ensures full compliance with SFDA regulations and supports business growth by securing timely approvals and renewals for our portfolio.

Job Responsibilities

• Manage product registration, renewal, and variations with the SFDA.
• Ensure compliance with SFDA guidelines covering pricing, labeling, and packaging.
• Prepare, review, and submit complete regulatory dossiers.
• Liaise with SFDA officials to resolve queries and secure approvals.
• Monitor changes in KSA pharmaceutical regulations and update management on implications. Support B2B partnerships by providing regulatory expertise for new product launches.
• Maintain accurate regulatory documentation for audits and inspections.
• Provide training and guidance to internal teams on SFDA compliance processes.

Requirements

• Bachelor's degree in Pharmacy (BPharm) is mandatory (Master's preferred).
• 7+ years of regulatory affairs experience in the pharmaceutical industry, including strong exposure to the KSA market.
• Proven record of successful SFDA product registrations and renewals.
• Deep knowledge of KSA pharmaceutical laws, pricing policies, and compliance frameworks.
• Strong communication and stakeholder management skills.
• Fluency in English & Arabic

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.

• Manage communication with SFDA authorities for product approvals and renewals.

• Track and interpret new regulations impacting medical device compliance.

• Maintain product registration database and ensure documentation accuracy.

• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor’s degree in Pharmacy, Biomedical Engineering, or Science.

• 8+ years of experience in Regulatory Affairs for medical devices.

• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.

• Strong documentation and submission management skills.

• Excellent English communication.

Regulatory Affairs TSO Manager KSA page is loaded Regulatory Affairs TSO Manager KSA Apply locations SA Riyadh time type Full time posted on Posted 4 Days Ago job requisition id JR2036 ARA-P3-12

Regulatory Affairs TSO Manager

Location: Riyadh, KSA

Department: Regulatory Affairs

Job type: Permanent

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

The Team

The role will join the Regulatory Affairs team in Riyadh, accountable for the regulatory affairs in Saudi, driving optimal regulatory outcomes and ensuring governance on regulatory activities. You will support PV Operations leadership as needed and act as TSO manager in KSA on behalf of the company.

Role and Responsibilities

• Ensure full compliance to all local and international regulations, codes and standards and company SOP.
• Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives.
• Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.
• Ensure filing strategy is aligned with global strategy.
• Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
• Ensure maintenance of appropriate systems for Regulatory activities and documentation.
• Ensure regulatory budget is prepared and maintained and aligned with global budget requirements.
• Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate.
• Ensure validity of Scientific Office licenses based on Local HA regulations.
• Respond to authorities’ inquiries related to Scientific Office.

What you’ll bring

• Bachelor’s degree or equivalent or higher, in Pharmacy
• Saudi National with a Pharmacist license from the Saudi Council of Health Specialities
• At least 5 years’ experience in regulatory affairs dealing with a wide variety of registration projects and issues.
• Experience in dealing with Pharmacovigilance matters.
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
• Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources.
• Strong initiation and organization skills
• Outstanding written and oral communication and negotiation skills.
• Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities
• Good technical skills in the local HA online submission system or equivalent systems

What we offer in return

• Opportunities for learning & development through our varied programme
• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focussing on customers 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 as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit

Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.

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:

Arthur Lawrence is urgently looking for a Senior Regulatory Compliance Manager for a client in Riyadh, KSA.

• Kindly review the Job requirements below.

Your immediate application will enable us to place you successfully.

Must-Have : 10+ years of experience in a regulatory compliance, legal, or risk management role within financial services or fintech.

Strong knowledge of Saudi financial regulatory frameworks (SAMA), particularly Consumer Protection regulations.

Experience working closely with product, engineering, and legal teams in a fast-paced, agile environment.

Proven ability to interpret regulatory requirements and design practical compliance solutions.

Excellent communication and stakeholder management skills, including experience interfacing with regulators or banking partners.

Ability to work independently, make sound decisions, and manage competing priorities.

Nice to have : Bachelors degree in Business Administration, Law, Finance, or Accounting Certifications in CRCM, CAMS, CRCMP, or PMP preferred About Us : Arthur Lawrence is a management and technology consulting firm providing enterprise-wide business transformation and business applications implementation services.

Our in-depth technical knowledge and broad experience of working with world-class companies enables organizations to leverage our capabilities in developing winning strategies and cost-effective solutions.

We are an UN Women Empowerment Principal Signatory and are certified from National Minority Supplier Development Council.

Acknowledgements from Industry Peers : Winner of Entrepreneur 360 Award (2019).

IAOP Award; Ranked in top 100 internationally.

Arthur Lawrence ranked within the Inc 5000 twice in 2016 and 2017 as one of the fastest.

Growing companies of America.

Named one of the top ten fastest growing businesses in Houston in 2016.

Ranked 25th in the HBJ s Fast 100 Private Companies Award in 2017.

Our Seven Pillars : We rely on the seven core values that we believe enable us to deliver quality for our consultants and clients : Education, Integrity, Value Creation, Collaboration, Best Client, Best People and Stewardship Through strict adherence to these core values, we have achieved success beyond all documented forecasts and anticipation.

Leverage your abilities and join the dynamic team of a leading company specializing in the retail industry in Saudi Arabia, Riyadh.

As a Regulatory Compliance Officer you will be responsible to ensures that all company activities fully comply with local and international laws, regulatory requirements, and internal policies. This role is responsible for monitoring compliance risks, reviewing internal procedures, conducting audits, coordinating with regulatory bodies, and providing guidance to management on required actions.

• Ensure company operations comply with all relevant laws, regulations, and internal policies.
• Review and analyze internal systems, procedures, and policies to ensure regulatory alignment.
• Identify and assess compliance risks, proposing and implementing mitigation plans.
• Conduct regular audits and inspections to verify adherence to compliance standards.
• Prepare comprehensive reports on compliance status and follow up on corrective actions.
• Maintain continuous communication with regulatory and government authorities to ensure the company meets all obligations.
• Provide regular compliance updates and recommendations to senior management.
• Organize and maintain all compliance-related documentation such as reports, certifications, and audit records.
• Monitor regulatory changes and advise management on their potential impact and implementation.
• Ensure business practices meet ethical standards and promote integrity across the organization.
• Conduct and evaluate employee training programs on compliance policies and procedures.
• Adhere to all company policies, procedures, and operational standards.
• Support the continuous improvement of compliance systems and processes to enhance efficiency and reduce risks.
• Promote awareness and enforcement of governance, risk management, and compliance practices across departments.

We are Looking for:

• Bachelor's degree in Law, Business Administration, Finance, or a related field.
• 4–6 years of experience in compliance, internal audit, or a similar field.
• Strong knowledge of local and international laws and regulations relevant to the retail sector.
• Excellent analytical, organizational, and problem-solving skills.
• Strong communication and reporting skills with the ability to coordinate across teams and management levels.
• Good understanding of governance, risk management, and compliance frameworks (GRC).
• Proficiency in Microsoft Office and familiarity with compliance management tools.

About HSBC:

HSBC Saudi Arabia provides investment banking services to the full spectrum of corporate and institutional clients in both the private and government sectors, including public companies; private companies and establishments; funds; government agencies; and family businesses and offices.

Main Responsibilities for the role:

• Support the implementation and monitoring of Compliance policies, procedures.
• Monitor CMA and Tadawul Regulatory updates and support necessary changes to internal policies and communications.
• Assist in compliance reviews, reporting, and maintenance of records.
• Support monitoring of Personal Account Dealing activities.
• Assist in providing compliance support to the business, including training and regulator requests.