CMC dossier leader
Sanofi
August 29, 2026
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Operations
Main Responsibilities:
- Lead, coordinate, and manage CMC dossier preparation and development processes.
- Drive alignment between dossier strategy and CMC activities to support expedited pathways to clinic and patients.
- Lead CMC sub-teams (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers.
- Ensure timely delivery of CMC dossiers for regulatory submissions (e.g., IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA; Health Authority information requests).
- Ensure consistent information across CMC dossiers and with other modules (clinical/preclinical).
- Contribute to submission templates and authoring guides with CMC, GRA CMC, and Digital teams.
- Support M&A/licensing due diligence by assessing CMC dossier content.
- Drive AI-powered solutions and digital tools to transform CMC regulatory document preparation.
About You (Qualifications & Skills):
- PhD, MS, or other degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth, superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of CMC development experience; proven CMC dossier authoring track record.
- Knowledge of synthetics CMC (at least one): chemistry, drug product/formulation & manufacturing, analytical development, or process/method validations.
- Understanding of regulatory document needs for development milestones and agency interactions.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
- Ability to lead cross-functional teams; strong issue-resolution/facilitation skills.
- Proficiency: Vault RIM, Word, Adobe.
Benefits (explicitly stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Lead, coordinate, and manage CMC dossier preparation and development processes.
- Drive alignment between dossier strategy and CMC activities to support expedited pathways to clinic and patients.
- Lead CMC sub-teams (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers.
- Ensure timely delivery of CMC dossiers for regulatory submissions (e.g., IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA; Health Authority information requests).
- Ensure consistent information across CMC dossiers and with other modules (clinical/preclinical).
- Contribute to submission templates and authoring guides with CMC, GRA CMC, and Digital teams.
- Support M&A/licensing due diligence by assessing CMC dossier content.
- Drive AI-powered solutions and digital tools to transform CMC regulatory document preparation.
About You (Qualifications & Skills):
- PhD, MS, or other degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth, superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of CMC development experience; proven CMC dossier authoring track record.
- Knowledge of synthetics CMC (at least one): chemistry, drug product/formulation & manufacturing, analytical development, or process/method validations.
- Understanding of regulatory document needs for development milestones and agency interactions.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
- Ability to lead cross-functional teams; strong issue-resolution/facilitation skills.
- Proficiency: Vault RIM, Word, Adobe.
Benefits (explicitly stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.