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Job Details

*Regulatory Affairs Senior Manager CMC Biologics * Brussels* * Provide Strategic leadership for CMC Bio projects * Excellent pipeline and great Salary

Company: Advanced Regulatory (UK & Europe)
Location: Brussels, Belgium
Reference: TMADV / 031016D
Closing Date: 14 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: On Application

Job Summary:

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. If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com 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 +44 (0)20 7801 3380.

Requirements:

*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.

The role:

  • 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.

Background 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

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If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com 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 +44 (0)20 7801 3380.
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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, CMC, Biotech, biotechnology, IMPD, BLA, IMD, CMC, Bio, Biotechnology

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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