Regulatory Affairs CMC Associate Manager 

Job type:
22 months
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 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, good German skills are a plus

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: 22MM+
Location: Basel, Switzerland
Ref.Nr.: BH12370

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