Senior Regulatory Coordinator – Hyderabad, India
Location: Hyderabad (Office), India
Job ID: REQ-10055990
Job Type: Full-Time | Regular
Business Unit: Development | Novartis Healthcare Private Limited
Salary:
Estimated range: ₹10 – ₹18 LPA
(Salary may vary based on experience, qualifications, and internal company policies. Additional benefits and rewards applicable.)
Position Summary:
Novartis is seeking a Senior Regulatory Coordinator to support development and life cycle maintenance projects through regulatory registration and post-approval stages. This role is vital for ensuring the timely delivery of regulatory components such as certificates, samples, and documentation to meet marketing authorization requirements.
Key Responsibilities:
Coordinate and procure essential regulatory documents including GMP certificates, registration samples, and COAs.
Collaborate with internal stakeholders such as NTO, Reg CMC, Global Labelling, and RA Ops to meet submission and renewal needs.
Represent the Regulatory Affairs LCM BOE team in global and regional project meetings.
Ensure readiness for submissions and approvals by aligning with line functions and country organizations.
Track project timelines, dossier deliveries, and ensure compliance with global and local regulatory requirements.
Maintain country requirement lists, support regulatory surveys, and contribute to excellence initiatives.
Participate in lessons learned and training sessions to enhance common regulatory strategies.
Qualifications & Experience Required:
Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
3–5 years of experience in Regulatory Affairs or pharmaceutical industry-related roles.
Strong communication and planning skills with the ability to thrive in a matrix environment.
Fluency in English (written and spoken) required.
Why Join Novartis?
Be part of a global organization driven to reimagine medicine and impact patients' lives. At Novartis, you'll work alongside passionate professionals in a culture of inclusion and collaboration. Learn more about our values and people-first mission here: Novartis People & Culture
Accessibility & Accommodation:
If you require assistance or reasonable accommodations due to a disability, please contact:
📧 diversityandincl.india@novartis.com (Include Job ID in your message)
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