Regulatory Affairs Manager
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.
