Senior Regulatory Manager

We are looking for a Regulatory Affairs professional with hands-on experience in biologics / biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance.

Key Responsibilities :

• Prepare, review, and submit regulatory dossiers (CTD / eCTD or country-specific formats) for biosimilars in Emerging Markets.
• Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa.
• Support product registrations, renewals & variations.
• Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management.
• Respond to health authority queries in coordination with CMC, clinical, and quality teams.
• Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
• Understand local regulatory pathways for biosimilars / biologics : reliance, abridged reviews, priority review, etc.
• Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines.
• Experience working with local affiliates or partner companies in Emerging Markets.
• Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc.
• Experience with regional electronic submission platforms.

Qualifications :

Show more

Show less

Skills Required

ectd, biosimilars , biologics , Regulatory Submissions