Regulatory CMC Facilitator

Job description

Job Description

The Regulatory CMC Facilitator will report to the Site Quality Head at Novartis BioProduction Operations Singapore.

Job Purpose
Manage and facilitate all on-site regulatory CMC related launch and post-approval activities of the site specific products, as well as the establishment and maintenance of site regulatory systems and procedures.

Key Responsibilities
• Act as single point of contact and advisor for worldwide regulatory intelligence information on the site. Maintain a close collaboration with Global Reg CMC in order to keep track with new regulatory requirements, Global Reg CMC strategies and the knowledge of the global product dossiers (CTD module 3)
• Plan, establish and maintain the site systems/ procedures related to regulatory activities. Support site in setting standards for regulatory relevant information included in CMC modules (e.g. specifications for raw materials)
• Act as member of the local change control review board and advise contributors (e.g. the Process Units (PU’s) and QA/QC) on the regulatory relevance of change requests, provide general strategic regulatory support
• Perform the product independent pre-evaluation of new change requests to assign/confirm category I or category II classification. 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. Follow up with Reg CMC for product specific regulatory issues after having consolidated all information available at the site.
• Support the site in generation of effective change control strategies particularly when changes affect a wide range of products or other sites/divisions. Coordinate with the global Reg CMC liaison manager in formulating the global regulatory strategy for the product changes.
• Support regulatory impact assessment of deviations and complaints within Quality
• Support the preparation of variation/ regulatory relevant documentation including the following:
- Facilitate timely provision of source documentation and accurate comments from technical experts to Global Reg CMC while ensuring regulatory compliance
- Facilitate the writing/ reviewing of CMC modules on site in line with agreed CMC regulatory strategies, assuring technical congruency, regulatory compliance, agreed upon timelines and e-publishing requirements
- Ensure the consistency of the CMC modules with source documents
- Support the preparation of CMC responses to health authority questions for site specific products
- Support the preparation of regulatory commitments and declarations. Prepare, coordinate and track regulatory commitments (“Statements / Commitments”) by maintaining an appropriate process.
- Follow-up the availability of necessary reports (e.g. stability reports) and perform quality checks. Monitor and follow-up on the preparation of samples in special cases (e.g. for stability or registration).
• Prepare, update and maintain the site master file. Ensure that the site master file is maintained with current-to-date information relating to the site’s facilities and manufacturing operations.
• Support site specific compliance activities. If requested provide regulatory status and relevant registration documentation for the compliance check.
• Coordinate maintenance of regulatory relevant site licenses and permits such as Poisons License, GMP certificate etc.
• Participate in self inspection activities. Provide regulatory support during local HA inspections.
• 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 keeping the highest level of compliance
• Participate in the CMC facilitator network sharing lessons learned and providing expertise to facilitators from other sites
• Act as the main site point of contact for local DRA for country-specific aspects

Desired profile

Minimum requirements

• Minimum Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Minimum 5 years in pharmaceutical manufacturing site, including minimum 2 years in Regulatory CMC
• Working knowledge of local and global regulations and submission and approval processes for New Chemical Entities (NCE) and product life cycle management
• Proven track record of successfully working in interdisciplinary teams and of simultaneously planning, coordinating and leading activities on multiple projects in Drug Regulatory Affairs
• Regularly demonstrated active contributions to line functions or project teams, e.g. change or site transfer teams as well as ability to contribute to matrix teams with the necessary strategic thinking
• Computer literacy in MS-project, Power Point, document management systems, databases and ability to quickly learn new software, tracking tools and associated processes
• Excellence in negotiation and communication skills as well as capability to influence others in a matrix organisation
• Excellent organizational skills
• Proactive and action-oriented attitude in driving projects
• Ability to represent the site in cross functional teams