Résumé
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients
even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
The Role:
This role offers hybrid working, requiring 3 days a week / 12 days a month based in office
As Global Program Regulatory Manager, you will work with the support of a RA Program Lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s).
The Global Program Regulatory Manager is also a member of the RA sub team and may lead or represent RA in regional or cross functional teams.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
