Global Program Regulatory Manager

vor 2 Wochen

Basel, Schweiz Novartis Vollzeit

394918BR

**Global Program Regulatory Manager (GPRM - Cardiometabolic)**:
Switzerland

**About the role**

26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs
We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.
Joining the Cardiometabolic development team as a Global Program Regulatory Manager, you will be able to contribute to continued successful development of therapies to manage chronic cardiac and metabolic diseases achieving health authorities’ approvals and enabling patients’ access as quickly as possible.
The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and may have responsibility for leading regional RA sub teams.
Your Responsibilities include, but are not limited to:

- Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans.
- Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally.
- Lead interactions with regulatory consultants/advisors for strategic input and challenge.
- Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate.
- Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy.
- May lead interaction with HAs during key HA meetings
- Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

Role Requirements:
What you will bring to the team:

- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Fluency in English as a business language. Additional language is an asset
- Experience with regulatory submission and approval processes in 1 or more major regions, as well as experience in a global/matrix environment or cross
- functional teams in the pharmaceutical industry, and in Health Authority negotiations
- 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: innovation in regulatory strategy; understanding of post-marketing/brand optimization strategies and commercial awareness preferred; involvement in a dossier submissions and approvals; Health Authority negotiations; drug regulatory submission and commercialization in region; analysis and interpretation efficacy and safety data; regulatory operational expertise
- Strong interpersonal, communication, negotiation and problem solving skills
- Basic organizational awareness (e.g., interrelationship of departments, business priorities)

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determin

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