Manager, CMC Development and Dossiers

Job Title: Manager, CMC Development and Dossiers

Location: Morristown, NJ

About the Job

The Manager, CMC Development and Dossiers is responsible for the coordination and authoring of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation.  Working closely with the respective SMEs, they support the writing and content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and quality documentation.  This is conducted ensuring alignment with Sanofi and global health authority requirements.  The position serves as representative on MSAT CMC and Technical Product Teams and works closely in coordination of technical writing support by M&S Hubs.

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:

• Collaborate closely with CMC Product Leaders and technical subject matter experts (SMEs) with pharmaceutical development studies, life cycle management activities, and manufacturing assistance projects to compile CMC documentation for technical reports for Regulatory and Quality purposes.

• Manage the authoring, development, and review of CMC dossiers (Modules 2 and 3) for regulatory submissions including, but not limited to, INDs, NDAs, IMPDs, and MAAs in eCTD format.

• Ensure all CMC documentation is accurate, aligned with project objectives, and compliant with regulatory guidelines.

• Serve as CMC technical representative to obtain source documentation, align on submission content, and communicate progress.

• Provide technical guidance ensuring alignment with current industry standards and best practices.

• Develop authoring and review timelines to meet regulatory submission deadlines utilizing retro-planning principles. 

• Organize and supervise MSAT activities with the M&S Hubs supporting the technical writing function.

• Collaborate closely with Global Regulatory Affairs (GRA) CMC to align on dossier strategies.

• Conduct team document reviews to facilitate resolution to comments.

• Support responses to information requests from Health Authorities.

About You

Qualifications:

• Bachelor’s degree in a scientific or technical discipline (e.g., bioengineering, chemistry, biology, pharmacy, or a related field) .  Advanced degree preferred.  

• 5+ years experience within a CMC environment

• 5 years of demonstrated experience with technical project support, manufacturing, quality, or CMC dossiers for regulatory submissions (e.g., Module 3 of CTD and eCTD structure).

• In-depth knowledge of pharmaceutical manufacturing processes, analytical methods, and quality control principles.

• Proficient with electronic document management systems (e.g., Veeva, Documentum).

• Exceptional technical writing, editing, and communication skills.

• Self-motivated, ability to prioritize, and manage multiple priorities.

• Excellent interpersonal and collaboration skills.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.