Regulatory CMC Manager

Job type:
on-site
Start:
06/2018
Duration:
n.a
Place:
Basel
Date:
06/14/2018
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 a relevant field
  • 5+ years' working experience as Regulatory CMC Manager along with production background
  • Domain knowledge in the pharmaceutical sector is an advantage
  • Languages: fluent English and German both written and spoken


Your tasks:
  • Operating as single point of contact and advisor for worldwide regulatory intelligence information on the site
  • Coaching the site's personnel on regulatory aspects of change management for handling change requests and maintaining regulatory compliance as well as supporting the site in setting standards for regulatory relevant information included in CMC modules
  • Providing support for the site in generation of change control strategies as well as verifying regulatory relevance of changes and guiding regulatory strategic as member of change control board
  • Supporting the CMC documentation preparation by provisioning good quality source documentation, including comments from technical experts to CMC of Regulatory Affairs while ensuring regulatory compliance, quality oversight and adherence to best practices
  • Ensuring on-site coordination, support and guidance for the preparation of CMC responses to Health Authority requests for site specific products
  • Disclosing issues regarding regulatory compliance checks and maintaining an oversight of any compliance remediation activities at the site


Start: ASAP
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH12970

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