Mgr Regulatory Affairs
Bangalore, India, 560064
Who we are
The opportunity
- Providing regulatory support for International Markets RA.
- Coordination of assigned regulatory activities.
How you’ll spend your day
- Document Management and Administrative Support
- Provide support for Certificate of a Pharmaceutical Product (CPP) requests across global and local markets.
- Manage requests for authorizations, certifications, and other regulatory documents; initiate requests as needed.
- Handle documentation requests from manufacturing or operational sites.
- Maintain and update trackers for ongoing regulatory projects and submissions.
- Develop and manage databases for regulatory updates, ensuring timely communication of new requirements or changes.
- Generate and compile reports from internal systems to support regulatory activities and decision-making.
- Regulatory Systems and Data Management
- Monitor and update market-specific regulatory changes in designated platforms.
- Upload and archive regulatory correspondence in relevant systems.
- Verify and match documents within content plans to ensure completeness and compliance.
- Oversee registration data management activities, with responsibilities evolving as processes develop.
- Maintain accurate documentation in Veeva Vault and other regulatory IT systems.
- General Regulatory Support
- Complete designated projects and tasks supporting international regulatory affairs, following internal procedures and under guidance from management.
- Coordinate, prioritize, plan, and monitor tasks related to assigned regulatory activities, ensuring alignment with timelines and business objectives.
- Develop and maintain subject matter expertise, proactively solving routine regulatory issues and escalating complex matters as appropriate.
- Communicate effectively with internal teams across regions and with external stakeholders.
- Guide and support junior team members, fostering knowledge sharing and professional development.
- Fulfill other allocated department duties and ad-hoc tasks as directed by senior staff.
- Complete assigned trainings in the internal learning management system within defined timeframes.
- Attend team meetings and provide regular updates on assigned activities and tasks.
Your experience and qualifications
- Masters in Pharmacy or Masters in Science/Life Sciences
- College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.
- 8-10 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
- Experience of regulatory documentation within Europe and/or International Markets.
Teva’s Equal Employment Opportunity Commitment