(Senior) Specialist Regulatory Affairs NCE (f/m/d) 100%

 — Bubendorf
Published: 20 mai 2022 | Position with re­spon­si­bil­i­ties | 100%

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.  

Bachem. Leading Partner in Tides 

In order to continue our organic growth, we are constantly looking for talent.

(Senior) Specialist Regulatory Affairs NCE (f/m/d) 100%

Your tasks

Within our innovative RA team, you will be responsible for:

  • Compiling regulatory documents (e.g. clinical trial regulatory dossiers, client data packages, DMFs) in line with regulatory requirements and customer's requests, according to the defined timelines
  • Developing dossier content strategies
  • Answering deficiency letters from Authorities
  • Performing regulatory assessment of changes as part of GMP change control 
  • Preparing regulatory documents to support post-marketing changes (e.g. "Variations") and submitting them accordingly, where applicable
  • Providing regulatory advice to and answering regulatory questions from internal and external customers, throughout the product lifecycle (including development)
  • Defining, communicating and keeping RA-related timelines for his/her projects
  • Representing RA in project teams for NCEs

 
Your profile

  • Master or PhD in chemistry or pharmacy or an equivalent qualification
  • Fluent in English and German
  • Flair for presenting scientific facts
  • Excellent written communication skills
  • Committed, creative, solution-oriented, well-structured work-attitude honoring timelines
  • Strategic mindset
  • Convincing attitude and persuasive communication
  • Understanding for concepts and principles
  • Experience in Drug Regulatory Affairs

 
We offer
We offer an exciting and challenging  position in a dynamic environment that guarantees you diversity. You will be joining a team of qualified specialists and you will be able to develop yourself professionally. In addition, we offer you the opportunity to work in an innovative environment and in a motivated team. You can expect modern terms of employment and attractive fringe benefits. If this interesting position appeals to you, then we look forward to receiving your application.
 
Interested? Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) via recruiting tool to Fabienne Carabelli