Regulatory Affairs Manager

CK Group
28 Aug 2020
25 Sep 2020
Jocelyn Blackham
Contract Type
Full Time
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.

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.

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