Samenvatting
About the Role
Key Responsibilities
- Lead compilation and submission of regulatory dossiers for new drugs, line extensions, additional indications, and lifecycle changes (renewals, site registrations, production transfers).
- Manage Clinical Trial Application (CTA) submissions and ensure compliance throughout study lifecycle.
- Support development and execution of regulatory strategies for pipeline products to enable timely market access.
- Ensure timely execution of post-approval regulatory commitments including PSURs, CMC variations, and labeling updates.
- Drive regulatory compliance tracking, including monitoring submissions, approvals, and ongoing obligations with Health Authorities.
- Collaborate with cross-functional stakeholders (Legal, QA, Supply Chain, Global teams) to ensure seamless regulatory execution and supply continuity.
- Support critical regulatory changes (e.g., site changes, legal entity updates, supply chain changes) with minimal disruption to business.
- Contribute to regulatory intelligence gathering and provide guidance on evolving regulatory requirements.
- Ensure data integrity and compliance through maintenance of regulatory databases and audit readiness.
- Drive process improvements, CAPA management, and compliance oversight to enhance regulatory efficiency and inspection readiness.
Essential Requirements
- Bachelor’s degree in Pharmacy / Life Sciences / Health Sciences/ Chemistry.
- 5 + years of hands-on experience in Regulatory Affairs within Indian regulatory framework, preferably in a multinational pharmaceutical environment.
- Strong experience in dossier compilation and HA submissions (NDAs, CTAs, lifecycle management).
- Good understanding of Indian regulatory requirements (e.g., CDSCO processes, clinical trial regulations, post-approval compliance).
- Strong cross-functional collaboration and stakeholder management skills.
- Effective communication (written and verbal) and interpersonal skills.
Desirable Requirements
- Post-graduate degree in Pharmacy / Life Sciences / Regulatory Affairs/ Chemistry.
- Exposure to global regulatory environments or working with HQ/overseas teams.
- Experience in regulatory strategy planning for new product launches.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
