About the Role
Major accountabilities:
Regulatory Strategy
- Provide input to global program regulatory strategy, including regulatory designations & innovative approaches.
- Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
- Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for HA interactions.
Regulatory Submissions
- Leads planning, preparation and submission of clinical trials.
- Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
- Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.
- Lead regulatory activities during HA reviews, responding to questions and HA interactions.
Regulatory Excellence & Compliance
- Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
Your Experience:
- Science based bachelors degree, plus an understanding of pharmaceutical development, clinical trials.
- Track record of involvement in regulatory or pharmaceutical development, in one or more major regions.
- Strong interpersonal skills and experience working in a complex, cross functional organization and leading cross function teams.
- Compliance and Quality mindset.
- Fluency in English.
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Role Requirements
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
