Regulatory Affairs Manager
- Employer
- CK Group
- Location
- Zürich
- Salary
- Competitive
- Closing date
- 25 Sep 2020
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Job Details
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.
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.
Company
Find the career you always dreamed of
We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.
We have 4 brands:
- CK Science is the leading independent scientific recruitment consultancy.
- CK Clinical is an established leader in the clinical research and drug development sectors
- CK Technical specialises in jobs for Engineers and IT professionals
- CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.
Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.
We are proud to be working with 18 out of the world’s top 20 scientific organisations.
We can help you find your dream job.
ckscience.co.uk
Company info
- Website
- http://www.ckscience.co.uk/
- Telephone
- +44 (0)1246 457700
- Location
-
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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