CMC dossier leader
Sanofi
5 hours ago
Remote friendly (Waltham, 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.
- Lead CMC sub team (Dossier Subgroup or 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 responses to health authority information requests.
- Ensure consistent information across CMC dossiers and other modules (e.g., clinical/preclinical).
- Contribute to submission template and authoring guide improvements 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’ professional experience in CMC development.
- Proven track record authoring CMC dossiers.
- Knowledge of synthetics CMC (at least one): chemistry, drug product development (formulation & manufacturing), analytical development, and process/method validations.
- Understanding of regulatory documentation for development milestones and agency interactions (consultations, inspections, responses to information requests).
- Knowledge of CMC dossier structures for clinical trials and market authorization.
- Leadership and facilitation skills for cross-functional teams; ability to resolve issues and move projects forward.
- Comfortable in digital-first environments; agility to embrace digital transformation/AI-ML applications.
- Proficiency in Vault RIM, Word, and Adobe.
Benefits (explicitly stated):
- Health and wellbeing benefits, including at least 14 weeks’ gender-neutral parental leave.
Skills to develop / Nice to have (if relevant):
- Advanced AI tools for document intelligence/automation; AI prompt engineering; agile/scrum; data integration platforms; digital quality management systems and electronic batch records.
- Lead, coordinate, and manage CMC dossier preparation and development processes.
- Drive alignment between dossier strategy and CMC activities to support expedited pathways to clinic.
- Lead CMC sub team (Dossier Subgroup or 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 responses to health authority information requests.
- Ensure consistent information across CMC dossiers and other modules (e.g., clinical/preclinical).
- Contribute to submission template and authoring guide improvements 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’ professional experience in CMC development.
- Proven track record authoring CMC dossiers.
- Knowledge of synthetics CMC (at least one): chemistry, drug product development (formulation & manufacturing), analytical development, and process/method validations.
- Understanding of regulatory documentation for development milestones and agency interactions (consultations, inspections, responses to information requests).
- Knowledge of CMC dossier structures for clinical trials and market authorization.
- Leadership and facilitation skills for cross-functional teams; ability to resolve issues and move projects forward.
- Comfortable in digital-first environments; agility to embrace digital transformation/AI-ML applications.
- Proficiency in Vault RIM, Word, and Adobe.
Benefits (explicitly stated):
- Health and wellbeing benefits, including at least 14 weeks’ gender-neutral parental leave.
Skills to develop / Nice to have (if relevant):
- Advanced AI tools for document intelligence/automation; AI prompt engineering; agile/scrum; data integration platforms; digital quality management systems and electronic batch records.