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Associate Director of Regulatory Affairs

  • Job type: Permanent
  • Location: Zürich
  • Salary: Competitive
  • Job reference: NYWH 17/01/18
  • Sector: EPM Scientific, Regulatory
  • Date posted: 17/01/2018
Associate Director of Regulatory 

A leading Pharmaceutical manufacturing company is seeking an experienced Associate Director of Regulatory required in Zurich. The Associate Director of Regulatory will be responsible for the Full Life Cycle Regulatory Submissions for their Biologics Rare-therapeutics business, communicating across business areas building strong working relationships to collaborate with colleagues and customers.

Company Overview

The company is a market leader in the production and distribution of biologics specialising in the development and production of rare and ultra-rare orphan diseases. The company prides itself on the quality of our services and our engaged culture, passionate about helping customers get new medicines to market.

Responsibilities:
  • Works with manager to develop and direct innovative and effective regulatory strategies in support of the assigned portfolio, pipeline and therapeutic areas.
  • May serve as global regulatory team leader on assigned programs.
  • Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
  • Prepares and executes aspects of US regulatory affairs, and ensures integration into global regulatory strategy.
  • Represents as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development. 
  • Coordinates submissions to FDA in support of proposed and ongoing development programs, e.g., new IND submissions, IND amendments, etc. 
 

Requirements:
  • 10+ 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, GLP & GCP 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.
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.a33ho1glgzd@epmscientific.aptrack.co.uk or phone +442037588855.



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