Hiring: Manager / Senior Manager – Regulatory Affairs (International Markets – Biosimilars & Biologics)

Location: Mumbai

Experience: 7+ Years

Reporting To: General Manager – Regulatory Affairs A leading global pharmaceutical organization is looking for an experienced Manager / Senior Manager – Regulatory Affairs to lead regulatory activities for Biosimilars and Biologics across international markets. The ideal candidate should possess strong expertise in global regulatory submissions, lifecycle management, and agency interactions for biologic products.

Key Responsibilities

- Develop and execute global regulatory strategies for biosimilars and biologics across international markets.
- Prepare, review, and manage dossiers (CTD/eCTD) for new registrations, renewals, variations, and lifecycle management activities.
- Coordinate with cross-functional teams including R&D;, Quality, Manufacturing, Clinical, and Supply Chain to ensure timely submissions and approvals.
- Drive regulatory compliance in line with ICH guidelines and country-specific requirements.
- Liaise with global health authorities, business partners,



and regulatory agencies to address queries and obtain approvals.
- Monitor evolving international regulatory requirements and assess their impact on product registrations.
- Support due diligence activities, regulatory intelligence, and portfolio expansion initiatives.
- Ensure timely execution of regulatory commitments while maintaining high-quality documentation and compliance standards.

Desired Candidate Profile

- Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
- 7+ years of regulatory affairs experience within the pharmaceutical industry.
- Hands-on experience managing International Regulatory Affairs exclusively for Biosimilars and/or Biologics.
- Strong exposure to global dossier preparation, submissions, lifecycle management, and regulatory compliance.
- Sound understanding of ICH guidelines, CTD/eCTD formats, and global regulatory frameworks.
- Excellent stakeholder management, communication, and project management skills.
- Ability to work in a fast-paced, cross-functional global workplace.

📌 Sr. Manager - Regulatory Affairs (Biosimilars/ Biologics) (Mumbai)
🏢 Bharat Serums and Vaccines
📍 Mumbai