Regulatory Affairs Manager CMC

Beschreibung

Regulatory Affairs Manager CMC- 6 months contract, Switzerland

We are searching for an experience regulatory affairs consultant to take on existing project in supporting tasks related to CMC submission of variety or products .

Responsibilities:

• 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).
• 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.
• 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 global interests.
• Maintain an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities.
  Requirements:
• University degree in scientific discipline
• Solid regulatory affairs experience in CMC for marketed products
• Prior experience working on the pharmaceutical production site

Michael Bailey International is acting as an Employment Business in relation to this vacancy.