Regulatory Affairs CMC Manager

Job type:
flag_no Switzerland

Project description:
This project is archived and not active any more.
You will find vacant projects in our project database.
Regulatory Affairs CMC Manager wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:
  • Degree in Science, e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent
  • 2+ years' work experience in regulatory affairs preferred as well as working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
  • Demonstrated track record of successful work in interdisciplinary teams, planning, coordinating and executing activities simultaneously on multiple projects
  • Ability to critically evaluate data from a broad range of scientific disciplines and a reasonable approach to risk assessment
  • Expertise in regulations, guidelines for NCEs and product life cycle maintenance
  • Languages: fluent English both written and spoken, well-spoken German desired

Your tasks:
  • Determining and leading global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
  • Communicating CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
  • Implementing all global CMC submission for assigned projects, while applying the global strategy into submissions
  • Authoring high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance
  • Maintaining a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products
  • Initiate and leading Health Authority interactions and negotiations as appropriate as well as driving cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development

Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13074

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:
  • All administrative questions
  • Finding an apartment
  • Health - and social insurance
  • Work permit and much more