Title: Manager / Senior Manager
- Regulatory Affairs (Biosimilars)

Location:
Mumbai Role Overview We are seeking an experienced Regulatory Affairs professional with robust exposure to biosimilar products and international regulatory markets. The individual will be responsible for driving regulatory submissions, managing product registration activities, ensuring compliance with global regulatory requirements, and coordinating with cross-functional teams to support timely market approvals.

Key Responsibilities

- Lead the preparation, compilation and assessment of regulatory dossiers for international product registrations.
- Manage CTD/eCTD and ACTD documentation in line with applicable regulatory guidelines and country-specific requirements.
- Work closely with manufacturing, quality, R&D; and other internal stakeholders to obtain technical information required for regulatory filings.
- Coordinate regulatory compliance activities and documentation with manufacturing facilities.
- Monitor submission schedules, regulatory milestones and responses to health authority queries to ensure timely execution.
- Conduct regulatory gap assessments and maintain accurate product and submission-related records.
- Review product-related change documentation, stability protocols,



clinical trial protocols and packaging/artwork materials from a regulatory perspective.
- Oversee product registration renewals, post-approval variations and regulatory updates across assigned international markets.
- Track evolving regulatory requirements in emerging markets and identify documentation needs for upcoming submissions.
- Maintain regular coordination with internal departments to ensure submission readiness and timely availability of required documents.
- Support regulatory activities involving global health authorities and international compliance frameworks. Desired Candidate Profile
- Any Science / Engineering graduate and postgraduate
- Proven experience in Regulatory Affairs with hands-on exposure to biosimilar products.
- Experience managing international regulatory submissions and product registrations.
- Strong working knowledge of CTD, eCTD, ACTD and ICH guidelines.
- Familiarity with regulatory requirements of international and emerging markets.
- Exposure to regulatory authorities and frameworks such as USFDA, EMA, WHO and MCC South Africa.
- Ability to coordinate effectively with manufacturing, quality assurance, R&D; and other cross-functional teams.
- Strong understanding of dossier management, regulatory compliance, variations and renewal processes.

📌 Manager / Senior Manager - Regulatory Affairs (Biosimilars) (Mumbai)
🏢 Selective Global Search
📍 Mumbai