We are looking for a Regulatory Affairs qualified with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, LATAM) 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, 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 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.

📌 Regulatory Affairs Manager (Bengaluru)
🏢 Biocon
📍 Bengaluru