Regulatory Coordinator Job at Novartis | Science/Pharmacy Candidates Apply Now
Join Novartis for the Regulatory Coordinator Job in India and contribute to the seamless submission and approval of pharmaceutical products. Candidates hired at Novartis play a pivotal role in ensuring regulatory compliance, coordinating with global teams, and supporting life cycle management of products in a dynamic pharmaceutical environment.
About Novartis:
Novartis India is a leading pharmaceutical company dedicated to reimagining medicine and improving the quality of life for patients across the country. With a strong focus on innovation, research, and regulatory excellence, Novartis delivers advanced therapies in multiple therapeutic areas. Guided by a purpose-driven approach, the company is committed to compliance, ethical practices, and building a healthier future for communities in India and beyond.
Novartis India offers rewarding career opportunities for professionals who want to create an impact in healthcare. As part of a global leader in pharmaceuticals, associates gain exposure to world-class innovation, continuous learning, and an inclusive culture that values diversity, growth, and collaboration. By joining Novartis for the Regulatory Affairs Job, you become part of a mission to improve and extend people’s lives.
Summary:
The Regulatory Coordinator at Novartis supports the development and submission of product registrations, progress reports, supplements, amendments, and periodic experience reports. The role ensures all registration activities comply with local pharmaceutical regulatory requirements.
Job Description:
- Job ID: REQ-10063144
- Location: India
- Posted On: Sep 30, 2025
Key Responsibilities:
- In this Regulatory Affairs Job, candidates getting hired have to procure key regulatory components, including certificates, GMP documents, registration samples, and COAs, in collaboration with internal and external stakeholders such as NTO, Reg CMC, Global Labelling, RA Ops, SCM, Tech Ops, Health Authorities (USFDA, Swissmedic, EMA), and consular services.
- Plan and manage the timely delivery of critical regulatory materials and authorized documents for product license renewals, site transfers, and new submissions globally.
- Represent the RA LCM BOE team in project meetings and global/regional regulatory discussions for new submissions.
- Coordinate regulatory readiness with line functions, country organizations, and regions to ensure timely submission and approvals.
- Track project progress, including timelines and dossier deliveries.
- Ensure quality and compliance with global and country-specific regulatory requirements and internal policies.
- Maintain country requirement lists, conduct surveys, and interact with country organizations as needed.
- Contribute to non-project initiatives, lessons learned sessions, and trainings to enhance regulatory strategies.
Minimum Requirements for the Regulatory Affairs Job:
- Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- 3–5 years of experience in Regulatory Affairs or related pharmaceutical industry areas.
- Strong interpersonal and communication skills.
- Ability to plan, prioritize, and work effectively in a matrix environment.
- Fluent in written and spoken English.
Why Novartis:
Novartis aims to reimagine medicine to improve and extend lives. Our vision is to be the most valued and trusted medicines company globally. Join a community of passionate associates driving innovation, collaboration, and breakthroughs that impact patients’ lives.
