Regulatory Affairs Manager

Employer
CK Clinical
Location
Zürich
Salary
Competitive
Closing date
26 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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CK QLS are recruiting for a Senior Manager, Regulatory Affairs to join a company in the pharmaceutical industry at their site based in Zürich on a 12-month contract basis.

Senior Manager Role:

The main purpose of the role will be to:
  • Be responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.
  • Manage assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region.
  • Ensure that all necessary applications are filed and maintained in compliance with applicable regulations.

Further responsibilities will include:
  • Collaborating with the RAV Europe Region Head and Lead (and LOCs as applicable) ensuring alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
  • Cooperating with key stakeholders and RAV Europe Region Head/Lead (and LOCs as applicable), managing overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements.
  • Supporting overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contributing to content for local label development.

Your Background:

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
  • Strong experience of pharmaceutical industry. Including prior regulatory experience or related experience in the vaccine area.
  • Vaccines and/or biologics experience is essential.
  • Understand and interpret scientific issues across projects as the issues relate to regulatory requirements and strategy.

This is an excellent opportunity to join an expanding and global company.

Apply:
For more information or to apply for this Regulatory Affairs Manager position, please contact CK Group, quoting job ref 48808.

Please send any correspondence in English.

It is essential that applicants hold entitlement to work in Switzerland.

As one of the leading specialist clinical recruitment companies in the UK, CK Clinical is here to help.

Since forming in 2004, CK Clinical has forged special partnerships with many of the top pharmaceutical and biotechnology organisations in the world. Working with a range of businesses from small independent start-ups to global blue chip pharmaceuticals providing quality staff. Our aim to help candidates find their dream clinical job has enabled us to expand into Europe, with us frequently placing people into jobs in countries such as:

  • Belgium
  • Holland
  • France
  • Switzerland
Contact Us
  • 9 High Street
  • Stevenage
  • SG1 3BG
  • GB
  • +44 (0)1438 743047
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