Summary
About the Role
Major accountabilities:
You will provide regular communications and briefings to Global and Regional Policy Heads on relevant global regulatory policy issues, participating in internal product team meetings to provide regulatory policy context for business decisions.
Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings. This follows analysis of the impact of important emerging regulatory policies and new requirements on Novartis projects and business.
Prepare and coordinate internal stakeholder feedback on proposed laws, regulations and guidance; represent and ensure Novartis’ position is considered by trade associations.
Serve as representative in external organizations such as trade associations, consortia, and/or Public Private Partnerships.
Identify and escalate internally key information with stakeholders, collaborating with Corporate Affairs to shape legislative proposals.
Coordinate and lead internal cross functional implementation of regulatory guidelines in new and emerging areas.
Your experience:
Bachelor’s or Master’s Degree, science, health policy or legal based.
Experience in regulatory affairs, and or Drug/ biologics development.
Demonstrable success in a regulatory or health policy role, with strong understanding of the regulatory and legislative environment.
Strong interpersonal, communication and negotiation skills. Ability to enable teams to think strategically.
Experience of working in a complex, cross functional environment, within either industry or HA setting.
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.
