CMC dossier leader
Sanofi
August 29, 2026
Remote friendly (Framingham, 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 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; Health Authority Information Requests).
- Ensure consistent information across CMC dossiers and with other modules (e.g., clinical/preclinical) and between dossiers.
- Improve 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 CMC regulatory document preparation.
Qualifications:
- PhD, MS, or other university degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth, superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
Required/Preferred Skills:
- Knowledge of synthetics CMC areas: Chemistry, drug product development (formulation & manufacturing), analytical development, and process/method validations.
- 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 to manage cross-functional/internal-external teams; strong issue-facilitation and communication.
- Ability to work in digital-first environments; proficiency in Vault RIM, Word, and Adobe.
- Nice to have: agile/scrum experience; data integration platforms; AI/ML knowledge; digital quality management systems/electronic batch records.
Benefits (explicitly stated):
- Rewards package; health and wellbeing benefits, prevention/wellness programs; 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 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; Health Authority Information Requests).
- Ensure consistent information across CMC dossiers and with other modules (e.g., clinical/preclinical) and between dossiers.
- Improve 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 CMC regulatory document preparation.
Qualifications:
- PhD, MS, or other university degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth, superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
Required/Preferred Skills:
- Knowledge of synthetics CMC areas: Chemistry, drug product development (formulation & manufacturing), analytical development, and process/method validations.
- 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 to manage cross-functional/internal-external teams; strong issue-facilitation and communication.
- Ability to work in digital-first environments; proficiency in Vault RIM, Word, and Adobe.
- Nice to have: agile/scrum experience; data integration platforms; AI/ML knowledge; digital quality management systems/electronic batch records.
Benefits (explicitly stated):
- Rewards package; health and wellbeing benefits, prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.