Senior Regulatory Manager

6 days ago

Bengaluru Karnataka India, Karnataka Biocon Biologics Full time

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:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.

• Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.

• Knowledge of CTD structure, Module 1 customization, and regional submission formats.

• Strong project management, communication, and stakeholder coordination skills

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