Regulatory Affairs Associate Manager – GCC

Regulatory Affairs Associate Manager – GCC

Full-time

The Associate Manager, Regulatory Affairs – GCC is responsible for managing regulatory activities across Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain to ensure timely product registrations, lifecycle maintenance, and compliance with local health authority requirements. The role supports the execution of regional business objectives through effective regulatory planning, submission management, and cross‑functional collaboration with internal teams and external agents.

• Manage regulatory activities for new registrations, renewals, variations, and other post‑approval submissions across GCC markets.
• Set and execute regulatory submission plans aligned with business priorities and product launch timelines.
• Coordinate the preparation, review, dispatch, and submission of regulatory dossiers in CTD/eCTD or country‑specific formats.
• Lead end‑to‑end submission activities and follow‑up with health authorities (through the agents) to ensure timely approvals.
• Serve as the main regulatory contact for local agents and support communications with health authorities.
• Coordinate responses to health authority questions, deficiency letters, and regulatory commitments with relevant internal functions.
• Monitor and communicate new regulatory requirements and assess their impact on ongoing and planned submissions.
• Collaborate closely with Global/Regional Regulatory Affairs, Medical, PV, Quality, Supply Chain, Commercial, Finance, and Labelling teams to support product registration and lifecycle activities.
• Support implementation and maintenance of local product information and labelling in compliance with local requirements.
• Prepare regulatory status updates, presentations, and reports for internal stakeholders and management.
• Lead or support additional RA projects and initiatives as assigned.

• Bachelor’s degree in pharmacy, Life Sciences, or a related scientific field.
• 5–7 years of experience in pharmaceutical regulatory affairs, within GCC markets.
• Strong knowledge of regulatory requirements and submission processes in Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.
• Experience in managing product registrations and lifecycle activities for innovative and/or specialty products is preferred.
• Strong organizational, communication, and project management skills.
• Ability to manage multiple priorities and work effectively with cross‑functional teams.
• Fluency in English and Arabic.

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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