Summary
About the Role
Major accountabilities:
Provide operational regulatory support for a portfolio of programs, Independently coordinating with other groups within RA to finalize and ensure timely dispatch of Health Authority submissions as aligned with assigned program RA sub-teams.
Contribute to or lead preparation of assigned Module 1 documents including forms and cover letters with oversight of the RA program lead(s). Support RA sub-team for clinical trial related activities (CTA forms and tracking, transfer of obligations submissions, drug shipment ticket review, etc.).
Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration and post-approval regulatory activities.
Ensure tracking and update of relevant regulatory information in Novartis compliance systems and trackers as provided by RA sub-team representatives.
May act as super-user and/or subject matter expert for selected topics or systems.
In some lifecycle management groups, support regulatory activity with a focus on divestment, portfolio rationalisation, procurement of samples and certificates, and new product planning.
Your Experience:
Bachelors degree preferred.
Pharmaceutical industry experience, ideal in regulatory operations.
Good interpersonal skills and experience working in a complex, cross functional organization.
Fast, flexible and focused on timely delivery. 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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
