Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00048808
  • Consultant:
  • Contact: 0041 (0) 782 508 535
  • Date Published: 28.08.2020
  • Sector:
  • Location: Zürich,
  • Discipline:

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 Jocelyn Blackham on 0044 1438 870 027 or email jblackham@ckqls.ch, quoting job ref 48808.

Please send any correspondence in English.

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

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