Regulatory CMC Manager
Regulatory CMC Manager wanted for our Basel based client in the pharmaceutical sector.
- 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
- 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
Location: Basel, Switzerland
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.
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RM IT Professional Resources AG
+41 58 356 06 86