Manager - Regulatroy Affairs - Switzerland, United Kingdom - CK GROUP

CK GROUP
CK GROUP
Verified Company
Switzerland, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

CK Group is recruiting for a Regulatory Affairs Manager to join a global pharmaceutical company who are patient-focused, values-based, R&D-driven company committed to bringing better health and a brighter future to people worldwide.

The position will bebased in Zurich, with some remote-working possible.
This is a contract role initially set to a 6 month duration with the potential to further extend


Salary:

In the region of 100 to 120 CHF per hour, depending on experience.


RESPONSIBILITIES:


Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.


Key duties will include:


  • Ensures regional regulatory strategies are written, reviewed and executed according to plan
  • In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
  • Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle
  • Partners with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authoritydecision making.

Experience/ Required Qualifications:


  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or postmarketing phases.
  • Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including postmarketing in the EU
  • Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
  • Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in either EU or US region (as relevant to role) with global involvement also preferred

Apply:

It is essential that applicants hold entitlement to work in the EEA. Please quote job reference 54906 in all correspondence.
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