Regulatory CMC Manager

Job type:
on-site
Start:
10/2017
Duration:
8 Months
Place:
Stein
Date:
10/10/2017
Country:
flag_no Switzerland

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
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