Beschreibung
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