Biocon Hiring Pharmacy Candidates for Regulatory Affairs Role – Apply Now
Looking for a Regulatory Affairs Job in the pharmaceutical or biotechnology industry? Biocon Careers offers an opportunity for regulatory professionals to work on biosimilar product registrations across the Middle East, North Africa (MENA), CIS, and Non-EEA markets. Candidates with a Pharmacy or Life Sciences background and relevant regulatory affairs experience can explore this opportunity.
- Job Position: Regulatory Affairs
- Location: Bengaluru, Karnataka
About The Company
Biocon is a leading biopharmaceutical company based in India, specializing in the development of biosimilars, generics, and novel biologics. With a strong commitment to innovation and quality, Biocon operates in various therapeutic areas, including diabetes, oncology, and autoimmune diseases. The organization is dedicated to enhancing patient access to affordable healthcare solutions globally. Regulatory affairs jobs at Biocon are pivotal in ensuring compliance with international standards and regulations.
Job Description
This RA Job at Biocon Careers focuses on developing and executing regional regulatory strategies for biosimilars. The role covers dossier preparation, regulatory submissions, health authority interactions, lifecycle management, regulatory intelligence, compliance, and cross-functional coordination across multiple international markets.
Key Responsibilities
- Develop regulatory strategies for biosimilar registrations.
- Prepare and submit CTD/eCTD dossiers.
- Manage regulatory submissions across MENA, CIS & Non-EEA markets.
- Coordinate with Health Authorities and regional partners.
- Handle variations, renewals and labelling updates.
- Monitor regulatory guidelines and ensure compliance.
- Collaborate with QA, QC, Clinical and Commercial teams.
Eligibility Criteria
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field. Regulatory certification is an added advantage.
- Experience: Regulatory Affairs experience in the pharma/biotech industry; MENA and CIS submission experience is mandatory. Biosimilars experience is preferred.
Required Skills
- Global Regulatory Affairs
- CTD/eCTD Submissions
- Biosimilar Regulatory Pathways
- MENA & CIS Regulations
- ICH Guidelines
- Lifecycle Management
- Regulatory Strategy & Compliance
- Project & Stakeholder Management
Why Join Biocon?
A Regulatory Affairs Job with Biocon Careers provides exposure to international biosimilar registrations, complex regulatory pathways, and cross-functional pharmaceutical operations. The role offers an opportunity to develop expertise across diverse global markets while contributing to the regulatory lifecycle of biosimilar products.
