Job Title: Manager – Global Regulatory Affairs
Location: Head Office, Bangalore, India
Company: Biocon Biologics
About Biocon Biologics:
Biocon Biologics is a leader in the biosimilars revolution, dedicated to providing high-quality, affordable healthcare globally. We aim to impact a billion lives with innovative, patient-centric solutions. Our multicultural environment fosters collaboration with partners and patients to achieve our mission.
Job Summary:
The Manager of Global Regulatory Affairs will develop and execute CMC regulatory strategies, manage marketing applications, and oversee lifecycle management for biosimilar products. This role requires collaboration across cross-functional teams and partners, ensuring compliance with regulatory requirements throughout product development and lifecycle.
Key Responsibilities:
| Responsibilities | Description |
|---|---|
| Develop and implement regulatory strategies | For global registrations of biosimilar products. |
| Coordinate cross-functional activities | Support product development, approval, and long-term planning. |
| Collaborate with partners | Execute global regulatory activities. |
| Manage development of 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 regulatory filings consistency | Maintain per regulatory requirements throughout product lifecycle. |
| Support clinical/non-clinical strategies | Development and execution. |
| Review and advise on CMC documents | Study concept documents, protocols, and reports. |
| Collaborate with partners and affiliates | Ensure effective implementation of global regulatory strategies and plans. |
| Develop risk management and contingency plans | Participate in the process. |
| Lead regulatory compliance | Ensure for biosimilar products. |
| Participate in regulatory meetings | Engage with Health Authorities. |
Knowledge and Skills:
- Comprehensive understanding of regulatory activities and product filings.
- Strong team collaboration skills.
- Familiarity with project management.
- Ability to understand and communicate scientific CMC information.
- Proactive in anticipating and preventing potential issues.
- Strong communication skills for articulating regulatory strategies and requirements.
Education/Qualifications:
- Required: B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc.
- Experience: Minimum 5 years in global regulatory affairs, preferably in advanced markets.
Meta Description:
Apply for the Manager of Global Regulatory Affairs at Biocon Biologics in Bangalore. B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc required.