Regulatory Affairs Associate Manager GCC
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Key skills for this role
About the Role
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 p.
Key Skills for This Role
Responsibilities
- Manage regulatory activities for new registrations, renewals, variations, and post approval submissions across GCC markets.
- Coordinate preparation, review, dispatch, and submission of regulatory dossiers in CTD/eCTD or country specific formats.
- Serve as main regulatory contact for local agents and support communications with health authorities.
Requirements
- Experience in regulatory affairs within GCC markets
- Knowledge of CTD/eCTD submission formats
- Strong communication and coordination skills
Full Job Posting
Role Overview
- 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.
Key Responsibilities
- 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.
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