Regulatory Affairs International Strategy Manager job in Zürich, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Operations

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

We currently have a maternity leave cover for a Regulatory Affairs International Strategy Manager Australia and Canada to join a regulatory team based in Zurich.

Job Responsibilities:

Creation of robust regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc.
Acts as a single point of contact for all regulatory affairs matters concerning the assigned sub region and/or partner companies
Plans all regulatory activities with the assigned partner companies/regional Hub and ensures timely execution
Budget the planned regulatory activities
Communicates with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels
Works with the legal department on the regulatory review of existing and establishment of new license agreements
Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
Ensures compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, Infrastructure and CMC
Keeps up to date with the latest regulatory requirements with the focus on the key markets (Canada, Australia).

Skills and Requirements:

Degree in Life Sciences
4 to 6 years of experience in Regulatory Affairs
Good command of English - both written and spoken
Experience in local Drug Regulatory Affairs in Australia and Canada
Experience of participation in local industry associations e.g. EFPIA
Ability to analyze the regulatory requirements, perform comprehensive gap assessments and build effective regulatory strategies
Project and matrix team management capabilities (direct/indirect people management experience is an advantage)
Computer literacy: advanced skills in Word, Excel and PowerPoint

To Apply

In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at 0203 761 5702 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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