Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): Negotiable
Regulatory Associate Lead CMC Location: Antwerp Area, Belgium Salary: €55,000-€70,000 depending on experience - Do you want to be a part of an innovative clinical-stage Biotech company?
Regulatory Associate Lead CMC
Location: Antwerp Area, Belgium
Job type: Permanent position
Salary: €55,000-€70,000 depending on experience
Job reference: J23478
- Do you want to be a part of an innovative clinical-stage Biotech company?
- Is CMC your area of expertise?
- Want to have day to day oversight of regulatory CMC activities with a focus on CMC submissions?
We are currently working with an innovative biotech company which has received massive funding in recent years. They focus on the discovery and development of small molecule medicines for immune-related diseases.
As the Associate Lead CMC you will be responsible for managing day to day activities for CMC submissions, obtaining and maintaining approvals
- Coordinate, prepare, submit and maintain Investigational Medicinal Product (IMP) documents in Clinical Trial Applications
- Prepare/ compile regulatory dossiers and briefing packages (such as scientific advice, eCTD module 3, quality IMPD)
- Regulatory Intelligence- create regulatory guidance summaries to support regulatory strategy
- At least 5 years"e; experience in CMC, having compiled and submitted CMC documents
- Strong theoretical and practical knowledge of the drug development process
- Previous experience in combination products is desirable
- Fluent English
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
Key words: Belgium, Flanders, Antwerp, Flemish, Netherlands, Biotech, Biotechnology, Manager, CMC, Regulatory Affairs, Regulatory Affairs Manager, Lead, Associate Lead, Drug development, clinical trials, early phase, strategy
3rd floor 33 Blagrave Street Reading
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