Job Details  
Advertiser: Haybury

 
Job Title: Global Regulatory Affairs Manager IN Cmc,
Location:Germany
Rate:£ Per Year    Benefits: Excellent
Description: My client, one of the world’s leading pharmaceutical companies who are headquartered in Germany, are looking for a strategic and capable individual to join their team in Regulatory and CMC.

You will be taking on important responsibilities as a Global RA Manager in CMC, supporting strategies and regulations, as well as being responsible for the development and implementation of adequate processes to ensure adherence to this policy.



Within this role:


• CMC representative on assigned New Product Development teams and related technical tasks
• Support transfer of manufacturing processes and analytical methods from R&D to Industrial Operations
• Write CMC dossier from CMC data package and coordinate a comprehensive project team review
• Align with the RA Technical Director to research and prepare the initial CMC strategy for timely registration of New Product with FDA, EMA and other world Regulatory Authorities
• Provide regulatory CMC expertise during Regulatory Affairs negotiations and interactions with regulatory agencies
• Work with functional experts to provide timely responses to CMC questions from regulatory agencies
• Lead technical task force meetings leading on RA/CMC related activities



You will bring to the role:


• Degree in pharmaceutics (such as MSc, PhD, MD)
• Extensive medical, scientific and/or technical knowledge within the pharmaceutical industry
• Excellent knowledge of CMC regulatory procedures
• Excellent communication, presentation and influencing skills
• Ability to maintain strong working relationships cross functionally
• Fluency in English



In return you will receive:


• An excellent salary package including relocation support
• The opportunity to work in a Global and state of the art environment
• Career growth opportunities



If you have the skills and experience for this opportunity and the ambition to take on this position, please call Briony for further details or email your CV today.

Contact Briony at +44 1273 727 930 or +49 6994 329 282 or briony.tutt@hayburysearch.com

Briony is a Search Consultant at Haybury Search covering Europe, UK, North America and Asia.



Keywords: Chemistry Manufacturing and Controls, CMC, Development, Biosimilar, LCM, Established, Senior, Regulatory Affairs, Manager, US, Strategy, Regulatory, Global, Strategic, Procedures, EMA, FDA, European, Cross Functional, Transfers, Guidelines, European, CMC, Manager, Submission, Chemie Manufacturing und Controls, Entwicklung, Gegründet, Strategie, Regulatory, Prozeduren, Richtlinien, Einreichung.
Skills Required: Chemistry Manufacturing and Controls, CMC, Development, Biosimilar, LCM, Established, Senior, Regula
Job Type: Permanent
Start Date: ASAP     Duration:
Contact: Briony Tutt Contact E-mail: Click
Contact Tel: 01273 727 930 Contact Fax: 01273 327 685
Reference: BT5730 Added: 01-08-2017
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
 
 
 
 
 
 
 
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