CMC Dossiers Leader

Job Title: CMC Dossiers Leader

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

The CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company’s product development through clinical phases to market authorization. We are seeking qualified individuals to join our US teams, which focus on supporting Sanofi’s innovative pipeline of Mammalian and Gene Therapy products.  

The CMC Dossiers Leader will lead, coordinate, and manage CMC dossier development processes and serves as the central contact point of a CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and document control to ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD /CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities). In the digital environment, the CMC dossiers leader will actively contribute to the reshaping of the Submission documentation in close collaboration with CMC functions and GRA CMC.

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 

• As a core member of the CMC project team and in close collaboration with Regulatory CMC, he/she develops dossier strategies to enable parallel development of CMC dossiers with CMC activities to force fast-to-clinic/fast-to-patients objectives.  

• Lead a dossier sub team comprising of SMEs from various CMC functions for dossier preparation. Provide authoring guidance, templates, regulatory storyline, tools, and way of working and resolve obstacles as they arise.  

• Lead authoring process, conduct team/management reviews, and facilitate resolutions to comments to ensure delivery of high-quality CMC dossier that is in alignment with project objectives and timelines.  

• Ensure consistent information presented throughout CMC dossiers and with other modules (e.g. clinical and preclinical) and between CMC dossiers 

• Prepare/write CMC summaries (e.g., Quality Overall Summary), introductions, reviewer guides, and regulatory documents (e.g. Investigator Brochure and Briefing Package) based on available CMC data.  

• Prepare and approve in Vault RIM the CMC sign-off sheet with the approved CMC documents and handover to GRA CMC for publishing.  

• Share lessons learned across the organization and provide state of the art guidance for dossier requirements.  

• Lead dossier activities with external partners and CDMOs.  

• Support M&A, in licensing due diligence activities by assessing the CMC dossiers content. 

• Review and/or approve CMC dossiers and act as CMC Dossier modality head delegate.   

• Guide and train new CMC Dossier Leaders and manage apprentices or trainees, GIGs & CMC helping hands.  

• Contribute to future digitalization & AI solutions in regulatory environment e.g.: digital dossier solutions for supporting future submission paradigm (ICH M4Q R2: revision of CTD M2 & M3 Quality section, augmented authoring initiatives) 

About You

Basic Qualifications 

• PhD, MS, other university degrees in one of the areas of biopharmaceutical drug development (e.g. pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry). In depth and superior knowledge in pharmaceutical development is mandatory. 5-10 years professional experience ideally in CMC development is required.  

• Proven records of leading CMC dossier development for clinical trial application or market registration submission (i.e., BLA/MAA/NDA)  

Required Knowledge and Skills:  

• Knowledge of at least one aspect of CMC development for Biologics and/or Synthetics: Chemistry, Cell line development, Formulation, DS/DP aseptic manufacturing, Analytical development, and Process and Method validations.  

• Experiences in writing of CMC dossiers sections - Knowledge of CMC dossier structures required for clinical trial and market authorization submissions.  

• Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests.  

• Leadership capabilities: ability to lead cross-functional teams with internal and/or external partners.  

• Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and contribute to cross-company projects.  

• Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges. 

• Ability to anticipate, prevent and resolve CMC dossier challenges by thinking out of the box.   

• Excellent oral and written English communication skills.  

• Facilitator skill to resolve issues and move project forward.   

• Organization skill for planning, time management, and communication.  

• Agility in priorities; readiness to adopt a TRT (thoughtful risk taking) culture. 

• Experienced in working with digital tools (e.g.: Vault RIM, Word and Acrobat) 

• Interest in new digital approaches and appetency for new digital software. Experienced in working with an agile methodology. 

• Constantly question and challenge status-quo and propose new ways of working, especially with a focus of digitalization 

Optional Skills:  

 CMC knowledge and experience in Cell/Gene Therapeutics is a plus.  

POTENTIAL CAREER EVOLUTIONS FOR JOB INCUMBENT 

• Larger responsibilities within CMC dossiers 

• CMC Project leader or manager 

• GRA-CMC 

• Quality manager 

• Other potential opportunities within the CMC field or Regulatory or Digital transformation  

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.