Regulatory CMC Manager

Vor Ort
8 Months
flag_no Schweiz

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Regulatory CMC Manager wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:
  • University degree in relevant field
  • At least 5 years' of professionalism in RegCMC with extensive production knowledge
  • Ability to identify needs and contribute in cross-site initiatives as applicable within and beyond the site context to improve and elaborate processes e.g. addressing gaps and/or achieving improvements in change control process
  • A Profound background in the pharmaceutical sector would be beneficial
  • Languages: fluent English and German both written and spoken

Your tasks:
  • Collaborating with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
  • Coaching, training and developing the site's personnel on regulatory specific aspects of change management and regulatory intelligence information
  • Facilitating timely provision of good quality source documentation, involving co-authoring as applicable and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices
  • Ensuring on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products
  • Addressing and resolving issues related to regulatory compliance checks, maintaining an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities

Start: ASAP
Duration: 8MM+
Location: Basel, Switzerland
Ref.Nr.: BH11701

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