Regulatory Affairs Associate Manager – GCC
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Key skills for this role
About the Role
Sobi seeks an Associate Manager, Regulatory Affairs for GCC markets to manage regulatory activities across Saudi Arabia, UAE, Kuwait, Qatar, Oman, and Bahrain. The role requires 5-7 years of pharmaceutical regulatory affairs experience in GCC and fluency in English and Arabic.
Key Skills for This Role
Responsibilities
- Manage regulatory activities for new registrations, renewals, variations, and post approval submissions across GCC markets
- Set and execute regulatory submission plans aligned with business priorities and product launch timelines
- Coordinate 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 to ensure timely approvals
- Serve as main regulatory contact for local agents and support communications with health authorities
- Monitor and communicate new regulatory requirements and assess impact on submissions
- Collaborate with Global/Regional Regulatory Affairs, Medical, PV, Quality, Supply Chain, Commercial, Finance, and Labelling teams
- Support implementation and maintenance of local product information and labelling
- Prepare regulatory status updates, presentations, and reports for internal stakeholders
Requirements
- Bachelor’s degree in pharmacy, Life Sciences, or 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, UAE, Kuwait, Qatar, Oman, and Bahrain
- Experience in managing product registrations and lifecycle activities for innovative and/or specialty products preferred
- Strong organizational, communication, and project management skills
- Fluency in English and Arabic
Full Job Posting
Company Description
- Sobi is dedicated to developing and delivering innovative therapies to improve lives of people with rare diseases.
- Sobi encourages applications from underrepresented groups.
Key Responsibilities
- Manage regulatory activities for new registrations, renewals, variations, and post approval submissions across GCC markets.
- Set and execute regulatory submission plans aligned with business priorities and product launch timelines.
- Coordinate 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 to ensure timely approvals.
- Serve as main regulatory contact for local agents and support communications with health authorities.
- Coordinate responses to health authority questions, deficiency letters, and regulatory commitments.
- Monitor and communicate new regulatory requirements and assess impact on submissions.
- Collaborate closely with Global/Regional Regulatory Affairs, Medical, PV, Quality, Supply Chain, Commercial, Finance, and Labelling teams.
- Support implementation and maintenance of local product information and labelling.
- Prepare regulatory status updates, presentations, and reports for internal stakeholders.
- Lead or support additional RA projects and initiatives as assigned.
Qualifications
- Bachelor’s degree in pharmacy, Life Sciences, or 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, UAE, Kuwait, Qatar, Oman, and Bahrain.
- Experience in managing product registrations and lifecycle activities for innovative and/or specialty products 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.
Additional Information
- Competitive compensation.
- Emphasis on work/life balance.
- Collaborative and team oriented environment.
- Opportunities for professional growth.
- Diversity and Inclusion.
- Making a positive impact to help ultra rare disease patients.
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