Regulatory CMC Facilitator, Biologics Drug Substance Supply

Job description

Job Description

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 and champion experience sharing within the site

Accountabilities:

Regulatory transmission:
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.

Change control:
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.

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. 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 Novartis global interests. Ensure overview and timely follow-up to commitments impacting the site.

Desired profile

Minimum requirements

Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
Desirable: Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology Fluent English (oral & written).
Good skills in site (local) language (oral & written).
4-6 years or more experience in pharmaceutical manufacturing site and/or QA/QC or in technical development; solid know-how in pharmaceutical technology; project management experience; 2 years or more experience in Regulatory Affairs CMC preferable..