Head of Regulatory Affairs, FDA Submissions

Location
Zug
Salary
£120222 - £153617 per annum + Bonus, Share options
Posted
Oct 12, 2016
Closes
Nov 11, 2016
Ref
MB/118407/885
Contact
Matt Beedle
Jobseeker Type
Professional
Organization Type
Clinical Practice
Contract Type
Employee
Hours
Full Time

Regulatory Affairs Director, NDA Submission, Zurich/Zug, Highly Successful Pharmaceutical Company, Switzerland

Interested in taking the lead on a new NDA submission? I am working with a fast growing pharma company who are looking to expand their regulatory team due to an internal promotion. As well as having a product in late stages, the company also have a solid product line that is already on the market. What we are looking for is someone looking for a new challenge, with experience of the FDA, who can manage both pre and post approvals. The company are very commercial; fast paced and are looking to build on their considerable success to date. Please contact me for further information.

Key Responsibilities:

  • LCM for pharma Rx products currently on the market
  • Play a leading role for an NDA
  • Management of a small team
  • Hands on input for submissions of critical regulatory documents
  • Overall a part of the business due diligence team

Key Requirements:

  • Over 8 years experience in pharmaceutical regulatory affairs
  • Fluency in English
  • Life science degree
  • Experience working on Pharmaceutical submissions to the US

For a confidential discussion about regulatory affairs, or to apply, then send your CV to m.beedle@nonstop-recruitment.com or call me, Matt Beedle, Regulatory Affairs Consultant for Switzerland on +41435 080817. For regular job updates and market information please join the Switzerland regulatory affairs linked-in group. https://www.linkedin.com/groups/4550988

I am a specialist head hunter(recruiter) for regulatory affairs in the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on the Swiss regulatory affairs market as well as ATMP(Advanced Therapeutics) and biological regulatory professionals world wide. Please refer to ch.linkedin.com/in/regulatoryaffairsswitzerland for references.

Specialties: *Switzerland Regulatory Affairs Market with a focus on German speakers *Biologics EU wide *Module 3, e-CTD, Chemistry Manufacturing and Controls(CMC) *ATMP, ATP, AT, Advanced Therapeutics, World Wide *Recruitment at all levels including associate, manager, senior manager, associate director, director, global director, senior director and vice president. *SwissMedic candidates