Regulatory CMC Manager
For our client, one of the world’s leading pharmaceutical companies, we are currently looking for a Regulatory CMC Manager
- Act as single point of contact and advisor for worldwide regulatory intelligence information on the site.
- Maintain a close collaboration 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).
- Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising issues for resolution.
- Coach, train and develop the site’s personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and maintaining regulatory compliance and support sites in setting standards for regulatory relevant information included in CMC modules.
- Support the site in generation of 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. Consider current regulatory requirements and trends in order to ensure accuracy and completeness of regulatory relevant information in the change requests while including potential regulatory hurdles. 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.
- 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. Ensure activities completed without delays. Address and escalate issues adequately and in time.
Health Authority Responses:
- 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 customer focus considering company’s global interests. Ensure overview and timely follow-up to commitments impacting the site.
- 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.
Qualifications and Experience:
- Bachelor degree in Science-related subject or other related field or equivalent work experience.
- At least 5 years experience of Reg CMC and production experience..
- Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
- Fluency in written and spoken in German and English
- Relevant working/residency permit or Swiss/EU-Citizenship required