CMC Document Lead

Department overview:

The CMC Dossier department within the Sanofi R&D Global CMC Development organization has the roles and responsibilities for leading the preparation and delivery of high-quality CMC dossiers for all pharmaceutical and biopharmaceutical products from First in Human clinical studies to Market Authorization Applications.

The CMC Dossier department has four modality group of which two have projects worked on in the Framingham US development site: Mammalian and Genomic Medicine Unit (GMU).

As part of the global CMC Dossier organization, these modality groups consist of scientists and/or regulatory CMC professionals who possess in-depth CMC product development experience and expertise, in particular in the area of Biologic products, including mAbs, enzymes, and gene/cell therapy products, and are well versed with the CMC dossier regulatory requirements and expectations.

Key Responsibilities

The CMC dossier leader will be in charge of mammalian and/or GMU projects, reporting dotted line to the head of the respective modality team and be responsible for the following:

• Represent CMC dossiers in the cross-functional CMC development team.
• Lead the cross-functional team in charge of preparing the concerned dossiers (Clinical trial application files, response to Authorities questions, Briefing packages for consultation of Authorities).
• Provide the expertise and guidance to all aspects of CMC dossiers throughout the product development cycles. In collaboration with the CMC and regulatory CMC partners.
• Develop dossier development strategies, execution plan and will coordinate with CMC experts from analytics, drug substance process development, drug product formulation and process development from R&D and/or industrial affairs, the final delivery of high-quality CMC dossiers in full alignment with the project milestone objectives and timelines.
• Manage pipeline products CMC dossiers for regulatory filing, agency communication and registration approval of clinical trial applications as well as marketing authorizations.
• Anticipate, propose and develop regulatory solutions for CMC technical challenges during the product development cycle.
• Write summaries, such as QOS, introductions, regulatory documents based on available scientific data, as well as reviewer guides.
• Ensure scientific consistency of information between different sections and documents.
• Ensure review, consolidation and resolution of comments. You will track preparation of dossiers, communicate on progress and ensure their timely delivery
• Ensure e-compliance status of quality documents and dossiers.

Basic Qualifications

• Master’s degree the fields of analysis, biological sciences, formulation and/or regulatory or related discipline with 8 years or a Bachelor’s degree with 10 years
• CMC Product development technical expertise in Biologics, to understand and support the CMC dossier
• Experience in a CMC development organizations and/or regulatory department with expertise in product development and demonstrated accomplishments in product development and CMC filings.
• Expertise and experience in one or more of the following areas: bio-research, bio-development including process development, analytical development and/or formulation development and/or GMP bio-manufacturing.
• Biologics CMC dossiers fluency. CMC dossiers include, but not limited to, clinical study applications (IND/IMPD/CTA), market authorization applications (BLA/NDA/MAA) and regulatory documents for major product development milestone regulatory agency meetings, inspections and written responses to CMC related questions. Successfully delivered CMC dossiers for regulatory submissions
• Proven experience in participating to writing of dossiers including answering HA questions
• Ability to anticipate, prevent and resolve CMC and/or CMC dossier problems.
• Excellent communication skills
• Ability to work in cross-functional project teams with internal and/or external partners

Preferred Qualifications:

• PhD in the fields of analysis, biological sciences, formulation and/or regulatory or related discipline with a minimum of 4 years of relevant industry experience, Experience in Biologics R&D development
• Experience in pharmaceutical/biotech industry and/or regulatory agencies with emphasis on CMC development or regulatory CMC
• CMC knowledge and experience in small molecule product development
• International experience (international assignments and/or multinational projects & teams)
• Experiences of participation to market registration authorizations of commercial products

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinatedagainst COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.