CMC dossier leader
Sanofi
August 29, 2026
On-site
Waltham, MA
$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 team (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers.
- Ensure timely delivery of CMC dossiers for regulatory submissions (IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA; and health authority information requests).
- Ensure consistent information across CMC dossiers and other modules (e.g., clinical and preclinical), and between dossiers.
- Contribute to improving submission templates and authoring guides with CMC functions, 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 preparation of CMC regulatory documents.
About You (Qualifications & Required Skills):
- PhD, MS, or other university degrees in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth and superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years’ professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
- Understanding of pharmaceutical environment, including digital transformation, economic, and regulatory challenges.
- Ability to embrace digital transformation and AI/ML applications.
- Knowledge of at least one synthetics CMC area: Chemistry; Drug product development (formulation & manufacturing); Analytical development; Process and Method validations.
- Comfort working in digital-first environments and adopting new technologies.
- Understanding of regulatory documents for milestones, agency consultations, site inspections, and written responses to information requests.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
- Leadership and cross-functional collaboration with internal/external partners.
- Issue-resolution and facilitation skills.
- Proficiency in Vault RIM, Word, and Adobe.
Preferred/Nice to Have:
- Experience with agile/scrum.
- Experience with data integration platforms.
- Knowledge of digital quality management systems and electronic batch records.
Benefits (explicitly stated):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
Application instructions:
- All compensation determined commensurate with demonstrated experience; employees may be eligible for company employee benefit programs.
- 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 team (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers.
- Ensure timely delivery of CMC dossiers for regulatory submissions (IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA; and health authority information requests).
- Ensure consistent information across CMC dossiers and other modules (e.g., clinical and preclinical), and between dossiers.
- Contribute to improving submission templates and authoring guides with CMC functions, 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 preparation of CMC regulatory documents.
About You (Qualifications & Required Skills):
- PhD, MS, or other university degrees in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth and superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years’ professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
- Understanding of pharmaceutical environment, including digital transformation, economic, and regulatory challenges.
- Ability to embrace digital transformation and AI/ML applications.
- Knowledge of at least one synthetics CMC area: Chemistry; Drug product development (formulation & manufacturing); Analytical development; Process and Method validations.
- Comfort working in digital-first environments and adopting new technologies.
- Understanding of regulatory documents for milestones, agency consultations, site inspections, and written responses to information requests.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
- Leadership and cross-functional collaboration with internal/external partners.
- Issue-resolution and facilitation skills.
- Proficiency in Vault RIM, Word, and Adobe.
Preferred/Nice to Have:
- Experience with agile/scrum.
- Experience with data integration platforms.
- Knowledge of digital quality management systems and electronic batch records.
Benefits (explicitly stated):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
Application instructions:
- All compensation determined commensurate with demonstrated experience; employees may be eligible for company employee benefit programs.