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Regulatory CMC Specialist

  • Job type: Permanent
  • Location: Basel
  • Salary: Competitive
  • Job reference: CMC Specialist
  • Sector: EPM Scientific, Regulatory
  • Date posted: 09/08/2017
Regulatory CMC Specialist

The Company:

My Client is a specialist in the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients. The firm provides a number of products and services to the pharmaceutical and life science industries, including organic fine and performance chemicals, custom manufacturing of biopharmaceuticals, chemical synthesis capabilities and new chemical entities, and services for the bioscience sector. In 2017, they are rapidly expanding and their current facility in Basel is currently acting as the Global Headquarters.

The Role:

Regulatory CMC Specialist

Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to a multi-disciplinary team. Support EU, US and global clinical trials and commercial license maintenance. Coordinate the preparation and timely submission of responses to regulatory agencies. Manage time lines to ensure approvals are timely and development objectives are met. Act as regulatory CMC representative at meetings with business partners and regulatory agencies for CMC related issues.

 Job Requirements

  • Established Regulatory CMC Background
  • Ability to adjust to new procedures/process quickly and effectively
  • Experience working with biologics or in an IMP environment is highly desirable
  • Fluent English essential, German desirable
  • Extensive knowledge of GLP/GMP/GCP
  • A Degree in a scientific discipline or quality related field 

If this a position you are interested in, please submit a copy of your most up-to-date CV in Microsoft Word format to;

 Or Call;

+0044 203 758 8784

Nicky Walsh

Head of Regulatory Management for EPM Scientific, Switzerland

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