*Regulatory Affairs Senior Manager CMC Biologics * Brussels* * Provide
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*Regulatory Affairs Senior Manager CMC Biologics * Brussels* * Provide Strategic leadership for CMC Bio projects * Excellent pipeline and great Salary
Take the Regulatory lead for a number of Biological projects (Vaccines or monoclonal antibodies) for a very highly rated Biopharmaceutical company that hires and retains the best. You will act as the CMC liaison and CMC expert for your projects, reviewing and building submissions. You will be working with an excellent pipeline in a strong team, where the focus is on high level strategic input. You will have all the support you need from authors and publishers.
My client is seeking professionals who can show leadership, high level influencing and persuading with an excellent cross-cultural awareness and understanding of the regulatory framework. You must be able to demonstrate strategic thinking and decision making and show excellent communication, interpersonal and relationship building skills. Ideally you will be a collaborative team player with excellent planning, organizational and project management skills who is proactive and flexible in your attitude and approach.
You will works across multiple functional and project teams as team leader and/or member and serves as technical "CMC" counsel to senior leadership Develops effective proactive CMC strategies for new products and for lifecycle in Europe. Acts as EU / International-CMC expert for review and finalising regulatory strategy documents and building submissions. Manage CMC aspects of projects/products, including major, complex applications submitted to regulatory agencies in Europe. Ensures that CMC regulatory submissions are complete and comply with applicable internal standards and regulatory requirements.
A minimum PharmD or science related BSc or MSc 5-10 years of technical/scientific/pharmaceutical or regulatory experience Knowledge in biological products and in Drug Development Process
If you wish to apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0). _____________________________________________________________________________________________
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