. Support and facilitate on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements. Champion regulatory compliance and consistency through representation in initiatives and experience sharing within and outside the site. About the RoleResponsibilities:Regulatory transmission:Act as single point of contact for worldwide regulatory intelligence information on the site.Maintain a partnership with RA CMC members / management and RA to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3).Collaborate on implementation of new regulatory requirements and provide guidance on regulatory and change control related aspects. Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising and resolving issues.Change control:Support the site in generation of effective change control strategies from a Regulatory Affairs CMC perspective.Verify and monitor regulatory relevant 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 to ensure accuracy and completeness of regulatory relevant information in the change requests while including potential regulatory hurdles.Submission support: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.Monitor project scope, timing and progress of submission-related activities e.G. transfers, ensuring activities completed without delays.Address and escalate issues adequately and in time.Health Authority Responses:Provide guidance and support for the preparation of CMC responses to Health Authority (HA) questions for site specific products, balancing internal and external customer focus considering Novartis global interests.Ensure overview and timely follow-up to commitments impacting the site.Declarations:Maintain oversight and ensure consistency; contribute to the establishment of standards; align requirements withRA CMC and RA, provide guidance to implementation of requirements into declarations; ensure alignment on content among all sites; ensure compliance to quality and regulatory standards. Coordinate or prepare declarations if needed