Manager, Regulatory CMC

Job Title: Manager, Regulatory CMC

Location: Morristown, NJ

Grade: L3-1

Hiring Manager: Jason Lande

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Mission

• Responsible for leading the authoring of CMC regulatory documentation to support new development & Life Cycle Management projects and Commercial products.

• Act, using advanced knowledge of CMC dossier strategy, as lead author and creator of content from CMC source documentation as needed for registrations and technical reports.

• Interface with broader Sanofi teams in Global Regulatory Affairs (GRA), Manufacturing and Supply (M&S) sites and External Manufacturing for outlining needs for change control assessments and dossier content, recommending to GRA table of content outlines for CMC submissions.

• Support these activities for submissions to global health authorities (i.e. FDA, EMA, Health Canada, and various ROW Markets).

• Assess progress made against dossier projects timelines and project targets adapting workplans and strategy in order to reach individual or team goals.

• Work with customers in GRA, M&S and R&D to assess their needs and enact solutions in the work environment to assure cooperation.

• Helps in the development of regulatory strategy for successful registrations and provide answers to questions received from regulatory authorities.

• Propose strategies for continuous improvements in CMC dossier activities to deliver efficiency gains.

• Works closely planning activities, with CMC Project Managers and Directors, specifically supporting details for CMC dossier activities.

• Acts as team representatives on CMC sub-teams and support MSAT on select Global Project and Industrial teams.

• Coordinates dossier writing work plans for post-approval projects with M&S External Manufacturing and Sites where support is provided.

• Responsible for guiding the writing support team on technical CMC aspects for the documentation as well as helping align project priorities.

• When M&S Regulatory CMC is the main component of the project, the Manager takes a leadership role of a multidisciplinary project team driving key deliverables and reporting to management.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Provides regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance.

• Supports the oversite of contract staff and planning of resource needs for writing activities of the BW MSAT team.

• Authors and compiles CMC dossiers for new NDAs and NDA supplements, annual reports, INDs, and DMFs for assigned products in eCTD format.

• Works closely with quality, manufacturing, Global Regulatory Affairs and technical staff throughout Sanofi worldwide locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.

• Contributes to R&D, LCM, M&S, CHC and Industrial Development projects by supporting CMC technical aspects and sub-teams.

• Ensures all dossiers are in compliance with appropriate SOPs, guidance’s, GXP and ICH guidance’s and maintain up to date knowledge.

• Communicates with Quality and Manufacturing site teams to request necessary content and documentation for regulatory submissions.

• Develops and maintain skills required for dossier related software systems used and included in regulatory filings.

About You

Knowledge, Skills, and Competencies:

• Excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a backgrou