Latest BSc Life Science Jobs at Novartis | Apply Now for Regulatory Coordinator Role
Are you ready to make a global impact in regulatory affairs? Novartis is hiring a Sr Regulatory Coordinator in India to support drug development and regulatory compliance. With a strong focus on diversity, innovation, and patient care, this role offers the opportunity to join a trusted global leader in the pharmaceutical industry. Discover how your experience in regulatory affairs can help reimagine medicine.
About Novartis
Novartis is a leading global medicines company focused on reimagining medicine to improve and extend people’s lives. Headquartered in Switzerland and operating in over 100 countries, Novartis combines cutting-edge science and digital technology to deliver transformative treatments across major disease areas. The company’s commitment to innovation, ethical responsibility, and patient-centric care makes it a trusted name in healthcare worldwide. Novartis also champions diversity and inclusion, striving to create a workplace that mirrors the rich diversity of the patients and communities it serves. By fostering a culture of collaboration and integrity, Novartis empowers employees to grow professionally while making a meaningful difference in global health.
Whether you’re a scientist, researcher, or regulatory expert, joining Novartis means becoming part of a purpose-driven organization
where your work truly matters.Job Opening: Sr Regulatory Coordinator
Job ID: REQ-10055990
Date: July 29, 2025
Location: Hyderabad, India
Summary:
The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support development, including line extension and /maintenance projects through development, registration, and approval, including post-approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects.
About the Role:
Key Responsibilities:
- Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA’s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals, SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers
- Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions worldwide (as per health authority requirements).
- For new submissions – Represents Regulatory Affairs LCM BOE team in NTO project team meetings, RA global and regional team meetings.
- Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for the timely delivery of submissions and approvals
- Track progress of assigned projects, including timelines and dossier deliveries.
- Ensure quality and compliance with global regulatory requirements, country requirements, and adherence to regulatory internal policies and processes
- Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations.
- Contribute to non-project-related initiatives and excellence activities
- Support lessons learned sessions and trainings within and external to RA GDD, leading to improved strategies and decisions on common regulatory approaches.
Minimum Requirements:
- BSc in Biochemistry, Biotechnology, Biology
- 3-5 years of experience in Regulatory Affairs
- Good interpersonal and communication skills
- Ability to work effectively in a matrix environment
- Fluency in English
Why Novartis: Join us in our mission to improve lives and become the most valued medicines company in the world.
Commitment to Diversity and Inclusion:
Novartis is devoted to creating an inclusive work environment that represents the patients and communities we serve.
Accessibility and Accommodation: For accommodation needs, please contact us at [email protected] with the job requisition number.
Join the Novartis Network: Stay connected with us for future career opportunities.
Link to the original notification to apply
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