Biocon Biologics Limited is hiring an experienced Regulatory Affairs Specialist in Bengaluru. This role is ideal for professionals with 5–8 years of regulatory affairs experience, especially in biosimilars submissions across MENA and CIS regions. If you have strong expertise in CTD/eCTD dossier preparation, regulatory strategy, and health authority interactions, this opportunity offers significant career growth in the biopharmaceutical sector.
This position plays a critical role in ensuring successful biosimilar product approvals, lifecycle management, and regulatory compliance across multiple international markets.
Key Responsibilities
Regulatory Strategy & Planning
- Develop and execute regional regulatory strategies for biosimilars in MENA, CIS, and non-EEA regions
- Align submissions with global regulatory frameworks and business priorities
- Conduct regulatory risk assessments and mitigation planning
Dossier Preparation & Submission
- Prepare, review, and submit CTD/eCTD dossiers for:
- Marketing authorizations
- Renewals
- Variations
- Coordinate with CMC, clinical, and labeling teams
- Ensure timely submissions as per regulatory deadlines
Agency Engagement
- Act as the primary contact for health authorities
- Lead regulatory discussions and approval processes
- Collaborate with regional partners for local submissions
Lifecycle Management
- Manage post-approval changes, renewals, and labeling updates
- Maintain regulatory databases and documentation
- Ensure compliance across all regions
Compliance & Regulatory Intelligence
- Monitor regional regulatory guidelines and policies
- Provide compliance updates and insights
- Support audits and inspections
Cross-functional Collaboration
- Work with QA, QC, Clinical, SCM, and Commercial teams
- Support business development and due diligence activities
Qualifications & Eligibility
- Bachelor’s or Master’s degree in Pharmacy / Life Sciences
- 5–8 years of regulatory affairs experience in pharma/biotech
- Strong knowledge of biosimilars regulatory pathways
- Experience with MENA and CIS regulatory submissions (mandatory)
- Familiarity with:
- ICH guidelines
- SFDA regulations
- EMA reliance procedures
Required Skills
- Expertise in CTD/eCTD submissions
- Strong project management and organizational skills
- Excellent communication and stakeholder management
- Ability to handle multiple regulatory projects
- Strategic thinking with high attention to detail
Salary & Benefits
- Estimated Salary: ₹12 LPA – ₹20 LPA (based on experience)
- Opportunity to work with a leading biologics and biosimilars company
- Exposure to global regulatory markets (MENA, CIS)
- Career growth in regulatory strategy and international submissions
How to Apply
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