Сводка
The RC collaborates closely with RA GDD Development and CMC teams, regional stakeholders (MoW, LACan, EU, China, Japan), NTO, and Quality Assurance to align planning, execution, communication, and successful completion of assigned projects.
About the Role
Major Accountabilities
- Ensure timely procurement of critical regulatory components (e.g., CPP, GMP certificates, registration samples, CoAs, and other regulatory documents) to support marketing authorization and lifecycle maintenance, in collaboration with internal functions (NTO, Reg CMC, RA Ops, Global Labelling, SCM, Tech Ops) and external stakeholders (Health Authorities, Consular Services, service providers).
- Coordinate regulatory readiness with line functions, Country Organizations, and Regions to enable on‑time submissions and approvals.
- Act as single point of contact for Regulatory Affairs in projects and governance forums (eg. NTO project teams and global/regional forums)
- Provide regulatory input on requirements, timelines, and risks for submissions and transfers.
- Proactively identify, manage, and communicate regulatory risks and mitigations.
- Track and manage project progress, including timelines, dossier deliverables, and regulatory milestones.
- Ensure quality and compliance with global and country‑specific regulatory requirements, and adherence to internal policies and processes.
- Demonstrate contribution to strengthen country intelligence, stakeholder alignment, and knowledge sharing within RA.
Minimum Requirement
- Minimum of 2 years of experience in Regulatory Affairs, related areas of the pharmaceutical Industry
- Strong communication, interpersonal, negotiation, and problem‑solving skills
- Proactive, delivery‑focused, with flexibility to meet stretch targets
- Demonstrates speed and agility while delivering timely outcomes
- Effectively plans, prioritizes, and manages workload
- Works confidently in a global matrix environment
- Builds strong, effective cross‑functional relationship
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
