The Regulatory Site Support supports regulatory compliance for both clinical and marketed products by means of correct and timely handling of all regulatory CMC activities.

The consultant manages regulatory activities associated to change controls, deviations and inspections including updating of CMC files and ensures the role of expert for all regulatory topics and projects on the manufacturing site.

The RSS performs/supports the performance of the following activities related to the assigned product(s) as per in house procedures:

1. Regulatory Compliance
   • Ensures that the CMC dossiers are and stay in line with implemented manufacturing and control procedures on site.
   • Act as regulatory expert within project teams and support project teams by providing accurate regulatory intelligence to ensure that proposals are aligned with current regulatory guidelines and expectations from Health authorities around the world.
   • Review and approval of GMP site documents to ensure these are aligned with registered details and regulatory guidelines. This includes product specific Specification Sheets, Stability Protocols and Reports, Validation and Qualification Protocols and Reports, Analytical and Process Comparability Plans and Reports
2. Change Control and Deviations
   • (Pre-)Asses the regulatory impact of proposed changes and manage their regulatory implications
   • Provide regulatory information as part of deviations to further assess the impact on regulatory compliance.
   • Act as the site’s regulatory interface with with Global Regulatory Affairs or with external partners.
3.  CMC and Regulatory Documentation management
   • Supports the writing of and/or authors CMC regulatory documents/dossiers and other supporting documents in a timely manner related to both clinical applications, marketing authorization applications and post-approval changes globally
   • Maintenance of Product Licenses and new registrations: this can include supporting periodic Product License renewals, creation of annual Product reports for Health Authorities, site registrations and transfers,…
   • Identify as early as possible, documentation required to support regulatory submissions and potential issues associated with the content, quality and/or timely delivery of these documents
   • Negotiate timely delivery of,high quality, technical source documents in accordance with project time-lines.
   • Supports the writing of and/or authors responses to Information request or deficiency letters received from Health Authorities in a timely manner. Both for CMC dossier related and inspection related queries.
4. Transversal activities
   • Acts as the primary contact person with Global Regulatory Aaffairs or with external regulatory partners