**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. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. _North America Applicants Only_ The salary range for this position is: $108,750.00 - $157,083.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)