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Global Program Regulatory Director

Company: Novartis Group
Location: Cambridge
Posted on: January 12, 2022

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. Read on to learn what you could do as part of our closely knit team.

** This role can either be based at the Cambridge, MA or East Hanover, NJ sites**

The Global Program Regulatory Director (GPRD) is a Regulatory Affairs leader, supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s), including drug, digital applications and medical devices, in close collaboration with the Global Therapeutic Area Lead (GTAL), as appropriate. Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more projects with little or no RA sub-team support as appropriate.

Your Responsibilities Include, but are not limited to:
--- Provide regulatory leadership to assigned project(s)

--- Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans

--- Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy

--- Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks

--- Responsible for development and implementation of the Regulatory Seed Document/ Regulatory Functional Plan

--- Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of program changes/information to support timely communication to Health Authorities globally

--- Partner with regions to align on strategy in order to fulfill business objectives

--- Acquire timely consultation with RA line management and Novartis advisory boards on strategy

EEO Statement 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. What You'll Bring to the role:
---Science based BS or MS with requisite experience and proven capability. Advanced degree (MD, Ph D, PharmD) preferred.

--- 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
- Innovation in regulatory strategy.
- 2-5 years of proven leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
- Global matrix management experience desirable.
- Experience in medical device and digital device registration is an asset.
- Good management, interpersonal, communication, negotiation and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams, and collaborating effectively with external development partners.

Why consider Novartis?

769 million. That's how many lives our products touched in 2019. 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:

Keywords: Novartis Group, Cambridge , Global Program Regulatory Director, Executive , Cambridge, Massachusetts

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