Senior Global Program Regulatory Manager (Radioligand Therapy)

326338BR
Aug 29, 2021
USA

Job Description

26 major approvals. 13 major submissions. 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.
Joining the oncology development team you will be able to contribute efforts towards the successful development of novel therapies or combination of therapies to fight cancer, achieve health authorities’ approvals and enable patients’ access to new treatment options to improve and extend their lives. Don’t miss this opportunity to reimagine medicine!

Your responsibilities will include, but are not limited to:
• Provide input into regulatory strategies for our innovative radioligand platform (a targeted radiotherapy, with radioligand imaging for patient selection) and take responsibility for their subsequent implementation under limited supervision
- Act as FDA liaison for assigned radioligand products

• Manage operational activities for assigned radioligand projects and regions (focus US) in accordance with applicable regulatory standards and within appropriate timeframes

• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required

• Lead or coordinate Health Authority meetings in assigned region(s) (focus US)

• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)

• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification

• Handle internal systems and tools that are needed to assess compliance

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
• Science Based BSc or MSc. Advanced degree (MD, PhD, PharmD) preferred.

• 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

• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: innovation in regulatory strategy;; involvement in a dossier submissions and approvals; Health Authority negotiations; drug regulatory submission and commercialization in region; analysis and interpretation efficacy and safety data; understanding of post-marketing/brand optimization strategies and commercial awareness; regulatory operational expertise

• Strong interpersonal, communication, negotiation and problem solving skills

• 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 determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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326338BR

Senior Global Program Regulatory Manager (Radioligand Therapy)

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