Description
Regulatory CMC Associate 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, advanced degree is desirable
- Working expertise in chemistry, biotechnology or pharmaceutical technology
- Knowledge of Regulatory Affairs and reasonable approach to risk assessment is a must
- Know-how in drug development process, regulations, guidelines for NCEs and product life cycle maintenance is desirable
- Competency of cooperating with multinational project teams and coordinating multiple projects simultaneously
- Languages: fluent English both written and spoken, desirably good spoken German skills
Your tasks:
- Preparing high-quality CMC documentation for Health Authority (HA) submission applying agreed CMC global regulatory strategies and assuring technical congruency as well as regulatory compliance
- Providing CMC responses to health authority questions during development, registration and product lifecycle
- Identifying required documentation for global submissions as well as content, quality and timeliness issues with source documents
- Keeping knowledge up to date with regard to regulatory guidelines, requirements and new technical trends in all global regions
- Contributing to the regulatory strategy, identifying the critical and establishing sound working relationships with partners and customers
- Supporting the general department regarding DRAGON (Drug Reg Affairs Global Regulatory Compliance System) annual and product renewal writing
Start: ASAP
Duration: 11MM+
Location: Basel, Switzerland
Ref.Nr.: BH12324
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