Description
Global pharmaceutical company is looking for a regulatory affairs manager CMC to support their already existing projects in chemical and biological products.The role is offered on 6 months contract but there is a chance to extend it.
Your tasks:
- single point of contact and advisor for worldwide regulatory intelligence information on the site.
- keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3).
- Executing effective change control strategies, Verify regulatory relevance of changes - includes performing regulatory pre-evaluation of changes, Provide regulatory strategic guidance as member of local change control board.
- Support the CMC documentation preparation by 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.
- Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products, balancing internal and external customers
Requirements:
University degree in life sciences
At least 5 years experience of RegCMC and production experience.
Experience in writing, reviewing and compiling CMC dossier for marketed products
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.