Manager – Global Regulatory Affairs
Location: Head Office, Bangalore, India
Company: Biocon Biologics
About Biocon Biologics:
Biocon Biologics is a pioneer in the biosimilars revolution, committed to making high-quality, affordable healthcare accessible worldwide. Our goal is to impact a billion lives through innovative, patient-centric solutions. As a global company, we foster a multicultural environment where our employees work closely with partners and patients to achieve our mission.
Job Summary:
The Manager of Global Regulatory Affairs is responsible for the development and execution of CMC regulatory strategies, marketing applications, and lifecycle management for biosimilar products. This role requires coordination across cross-functional teams, collaboration with partners, and ensuring compliance with regulatory requirements throughout product development and lifecycle.
Key Responsibilities:
- Develop and implement regulatory strategies for global registrations of biosimilar products.
- Coordinate activities and deliverables from cross-functional teams to support product development, approval, and long-term planning.
- Collaborate with partners to execute global regulatory activities.
- Plan and manage the development of high-quality regulatory documents, including briefing documents, CTAs, IND/IMPD, MAA/BLA, and responses to regulatory questions.
- Provide regulatory direction on global requirements to support product development.
- Ensure filings are maintained per regulatory requirements and are consistent with biosimilar strategy throughout product lifecycle.
- Support the development and execution of clinical/non-clinical strategies.
- Provide review, input, and regulatory advice on study concept CMC documents, protocols, and reports.
- Collaborate with partners and affiliates to ensure effective implementation of approved global regulatory strategies and plans.
- Participate in the development of risk management and contingency planning.
- Ensure and lead regulatory compliance for biosimilar products.
- Participate in regulatory meetings with Health Authorities.
Knowledge and Skills:
- Comprehensive understanding of regulatory activities and product filings.
- Strong team skills, with the ability to work effectively with internal and external partners.
- Familiarity with project management requirements.
- Ability to understand and communicate scientific CMC information.
- Ability to anticipate and prevent potential issues.
- Strong communication skills to articulate regulatory strategies and requirements.
Education/Qualification:
- Required: B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc.
- Experience: A minimum of 5 years in global regulatory affairs, with preference given to those with experience in advanced markets.