US-NJ, US CPO Regulatory CMC Facilitator 212561BR-MZ
US CPO Regulatory CMC Facilitator
East Hanover, NJ
Research & Development
Novartis is seeking a Regulatory CMC Facilitator to manage and facilitate all regulatory CMC related launch and post-approval activities (post approval changes, transfers, remediation, divestment, pruning and due diligence) of US CPO specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements.
Act as a single point of contact and advisor for world-wide regulatory intelligence information on the site. Maintain a close collaboration with Global Regulatory CMC in order to keep track with new regulatory requirements, Global Regulatory CMC strategies and the knowledge of the global product dossiers (CTD module 3)
Support CMO s 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 all contributors (e.g. the Technical Facilitators) and QA/QC) including the site change coordinator 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 Regulatory CMC for product specific regulatory issues after having consolidated all information available for US CPO.
Support US CPO in generation of effective change control strategies particularly when changes affect a wide range of products or other sites/divisions.
Support the variation documentation preparation by facilitating timely provision of good quality source documentation and accurate comments from technical experts to Global Regulatory CMC while ensuring regulatory compliance.
Facilitate the timely writing of high quality CMC modules on site in line with agreed CMC regulatory strategies, assuring technical congruency, regulatory compliance and adherence to best practices (e.g. LEAN).
Support the preparation of CMC responses to health authority questions for US CPO specific products.
Support US CPO specific compliance activities; e.g. participate in the remediation work stream. If requested provide regulatory status and relevant registration documentation for the compliance check.
Support preparation of regulatory commitments and declarations. Maintain overview on commitments impacting US CPO. Train and develop US CPO 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.
Provide regulatory support during local HA inspections
Participate in the CMC facilitator network sharing lessons learned and providing expertise to facilitators from other sites.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
BS Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Bio-technology, Biology) or equivalent.
Desirable: Advanced Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
English is required, foreign language is desirable; German is preferred, but not required.
2 or more years experience in Regulatory CMC preferable.
2 years or more experience working on a manufacturing site (e.g. QA, QC or production)or laboratory or equivalent experience from external company or other line function preferable.
Working Knowledge of local and global regulations and sub- mission 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 lead-in activities on multiple projects in Drug Regulatory Affairs (DRA)/TechOps or equivalent experience from external company or other line function.
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 organization
Excellent organizational skills.
Proactive and action-oriented attitude in driving projects.
Ability to represent the site in cross-functional teams
Ability and willing to work out of the East Hanover, NJ campus.
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