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

CK GROUP

Verified Company

Switzerland, United Kingdom

4 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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.