Regulatory Affairs Manager CMC 6 months contract
We are looking for a regulatory affairs consultant to join a challenging project to take charge for external and internal collaboration in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3).
Act as main point of contact for all regulatory specific aspects of change management, regulatory intelligence, handling change requests, maintaining regulatory compliance and support sites in setting standards for regulatory relevant information.
Provide regulatory strategic guidance to internal teams by following regulatory requirements and trends in order to ensure accuracy and completeness of regulatory relevant information in the change requests,
Identify any discrepancy in regulatory affairs reports and documents and contribute to improvement of change control processes.
Support the CMC documentation preparation by facilitating timely provision of good quality source documentation, co-authoring as applicable,
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,
Support and address issues related to regulatory compliance checks. Maintain an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities.
University degree in life science (pharmacy, biology, biochemistry or similar)
Prior experience in regulatory affairs function managing global CMC submission
Fluency in English and German
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.