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Regulatory Associate Lead CMC

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  • 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.

    Job Description:
    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

    Job Requirements:
    - 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


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