Sr Ext Partnerships Regulatory Manager

☞ Novartis

View: 147

Update day: 20-03-2024

Location: Basel Basel-Stadt BS

Category: Legal / Contracts

Industry: Pharmaceuticals

Position: Mid-Senior level

Job type: Full-time

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Job content

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.

The Senior External Partnership Regulatory Manager (Sr EPRM) will lead major RA GDD Global Programmes involving an external vendor. The Senior Manager will be a key member of the RA GDD External Partnership team, whose role is to define the strategy for Global Projects requiring external vendor participation and will enable the development and implementation of initiatives which have been assigned to the RA External Partnership Group.

Your responsibilities will include, but are not limited to:
  • Project Manage the development of specific vendor partnerships and/or manage efficiently existing partnerships with external service providers
  • Partner with Line Functions within GDD to negotiate issues/requirements for each assigned external project with the goal of achieving a successful resolution/implementation
  • Provide expert advice and leadership to GDD RA groups who are actively assessing vendors for approved initiatives by way of an RFP
  • Influence and negotiate according to project requirements with business partners/stakeholders
  • Support knowledge exchange through participation at lessons learned sessions
  • Participate in other functional projects which impact DRA External partnerships as required.
Minimum Requirements

What you’ll bring to the role:
  • University degree
  • Fluency in English, written and spoken. In addition, German is desirable.
  • Minimum 5 years’ experience in Drug Development. Regulatory experience is not mandatory but highly recommended.
  • Excellent Project Management skills
  • Knowledge of CTA and worldwide drug registration and approval processes and related document format requirements.
  • Excellent interpersonal, communication and presentation skills.
  • Skilled in preparation of documentation/training materials in English.
  • Ability to work under pressure of time; flexible, with effective prioritization of workload.
Why Consider Novartis?

799 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!

Division

Global Drug Development

Business Unit

REG AFFAIRS GDD

Country

Switzerland

Work Location

Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No
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Deadline: 04-05-2024

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