Senior manager Regulatory Affairs CMC
- Employer
- Warman O’Brien
- Location
- Belgium
- Salary
- Based on candidate's experience.
- Start date
- 17 Jan 2022
- Closing date
- 16 Feb 2022
View more
- Discipline
- R & D , Biotechnology, Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
This is a complete role in which you will be able to work on product in development. You will have full autonomy on the CMC writing. In addition, you will be participating in the strategy, meeting the health authorities for you to be able to grow and take more responsibilities in the future.
You will be working on Biologics products (ATMP), which will be really interesting in terms of development, as well as the scientific side. Moreover, you will be working on some first-in-class product that will can be a relief for the patients.
Your tasks:
- Define, participate, and challenge the CMC regulatory strategy.
- Preparation and submission of the CMC files for the BLA submission.
- Technical writing: (Module 3, 2.3)
- Prepare and interact with the health authorities (EMA, FDA) to respond to their questions.
Votre experience:
- You have a strong scientific background.
- At least 5 years of experience in the Pharmaceutical, Biotechnology industry on similar role
- You have been working with Biologics product in development (Ideally ATMP, Gene/Cell Therapy).
You can contact me via Linkedin or Email: brieuc@warmanobrien.com for a confidential conversation.
Company
Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:
- Biometrics
- Data Sciences
- Quality Assurance
- Regulatory Affairs
- Clinical Research
- Discovery Sciences
- C-Suite
- Medical Affairs
We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.
Find out more on our website warmanobrien.com/
- Website
- https://warmanobrien.com/
- Telephone
- +44 (0) 2033255075
- Location
-
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom
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