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Regulatory CMC Manager

  • Job type: Permanent
  • Location: Frankfurt am Main
  • Salary: Competitive
  • Job reference: NYWH 12/03/18
  • Sector: EPM Scientific, Regulatory
  • Date posted: 12/03/2018

Senior Regulatory Project Manager  

A leading Pharmaceutical development company is seeking an experienced Regulatory CMC Manager required in Frankfurt. The Regulatory CMC Manager will act as a key member of the Regulatory business, communicating across business areas building strong working relationships to collaborate with colleagues and customers.

Company Overview

My client is a market leader in the development and distribution of biologics including Proteins and Monoclonal Antibodies. The company prides itself on the quality of our services and our engaged culture, passionate about helping customers get new medicines to market.

Responsibilities:
  • 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, under the supervision of GRA-CMC leadership.
  • 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 representative at meetings with business partners and regulatory agencies for related issues.
 Requirements:
  • 5+ years Regulatory Experience.
  • Full Product Life Cycle Management.
  • Completed science degree, ideally in the field of chemistry or pharmacy.
  • All applicants must be eligible to work in the EU.
  • Fluent English.
  • Sound professional experience in the field of quality assurance and a strong knowledge of Regulatory in GMP regulated environments.
Package:
  • Ongoing training and career development.
  • Private healthcare and life assurance.
  • 30 days holiday (inclusive of bank holidays).
  • Group pension plan.
  • Employee of the quarter, food treats and staff parties.
  • Subsidised restaurant and have free parking at our site.
Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: apply.a33ho1gmzcc@epmscientific.aptrack.co.uk or phone +442037588855.

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