Job Description
1. Regulatory Strategy & Planning
• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.
• Ensure alignment with global regulatory strategy and business priorities.
• Conduct regulatory risk assessment and provide mitigation strategies during planning and execution.
2. Dossier Preparation & Submission
• Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for current marketing authorizations, renewals, and variations.
• Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission timelines are met as per business needs and agency expectations.
3. Agency Engagement & Partner Coordination
• Act as the primary point of contact for Health Authorities in these regions.
• Lead technical and administrative discussions with regulatory agencies to facilitate approvals.
• Collaborate with regional distributors/partners for local submissions and regulatory intelligence.
4.



Lifecycle Management
• Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting.
• Ensure timely implementation of changes across the region.
• Maintain up-to-date regulatory documentation and databases.
5. Compliance & Intelligence
• Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars.
• Provide periodic update on impact and compliance to regulatory head.
• Support regulatory inspections as needed.
6. Cross-functional Collaboration
• Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities.
• Support business development activities, due diligence, and partnership evaluations for the region.

Qualifications & Experience:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus.
• Experience in regulatory affairs in the pharma

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru