Regulatory Affairs Jobs at Biocon | Pharmacy Graduates | Apply Online
Looking for the latest Regulatory Affairs Jobs? Biocon Careers has announced an excellent opportunity for a Regulatory Affairs Manager to support biologics and biosimilars registrations across Emerging Markets, including the Middle East, LATAM, and Africa. Professionals with experience in CTD/eCTD submissions, regulatory compliance, and global product registrations can take advantage of these Regulatory Affairs Jobs through Biocon Careers to build a rewarding career in the biopharmaceutical industry.
Job Details
- Position: Regulatory Affairs Manager
- Location: Bengaluru, Karnataka, India
About the Company
Biocon Biologics is a prominent biopharmaceutical company based in India, specializing in the development of biologics and biosimilars. The organization operates in the pharmaceutical sector, focusing on innovative therapies to address unmet medical needs. Biocon is committed to providing high-quality healthcare solutions and has established a strong presence in various international markets. The company is dedicated to regulatory excellence, making it an ideal workplace for those seeking regulatory affairs jobs.
Job Description
The selected candidate will be a Regulatory Affairs professional with hands-on experience in biologics and biosimilars registration across Emerging Markets, including the Middle East and LATAM regions. Responsibilities include 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. This role is crucial for maintaining Biocon’s commitment to regulatory excellence in the field of biosimilars.
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, and 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 a 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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