Job

Datum
23.11.2018
Beschreibung

We make it GmbH, placed in Reinach BL, is a Swiss Recruitment success story.
As one of the market leaders, We make it recruits specialists for project assignments as well as for permanent employments all over Switzerland - quickly, in accord with your needs and reliably.
We make it is specialized in following areas: Information Technology, Administration, Engineering, Finance and Pharma.

For our client, headquartered in Basel, Switzerland and one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics, we are always looking for temporary or long-term assignments

 

Technical Drug Regulatory Affairs Manager

 

Pharma Technical Regulatory (PTR) acts as the center of excellence for all technical
regulatory activities for global development and marketed product. The Technical Drug
Regulatory Affair Manager in the Biotech Development Group sets and maintains the
technical regulatory standards for the Chemistry Manufacturing and Control (CMC)
submissions. You will be responsible for developing and executing regulatory strategies for products under development.

 

Key responsibilities:

  • Represent the technical regulatory function on cross-functional teams with respect to
  • Drug- and Device Combination Product
  • Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory Drug- and Device Combination Product issues
  • Successfully negotiate technical regulatory plans
  • Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
  • Apart from your proven Regulatory CMC experience with regards to preparation of
  • regulatory applications and submissions, planning of regulatory strategies, assessing
  • regulatory compliance and supporting quality systems, we require knowledge in
  • Biotechnology as well as Drug- and Device combination Product experience.

 

Further to these, we are looking for someone with the following skills:

  • University degree (Master or PhD) in a scientific discipline
  • Minimum 3 years of industry experience in regulatory, and Drug- and Device combination Product
  • Excellent communication, collaboration, and interpersonal skills
  • Effective problem solving and strong organizational skills, including ability to prioritize
  • tasks

 

Are you interested in this challengeing employment? Then forward your application form (in both PDF- & Word-Format) by e-mail to or by post to the adress underneath.


We make it GmbH
Herr Daniel Waser
Personalberater
Nenzlingerweg 2
4153 Reinach
0844844040
waser@we-make-it.ch
http://www.we-make-it.ch