CMC dossier leader
Sanofi
4 hours ago
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 a 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 health authority information requests.
- Ensure consistent information throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between dossiers.
- Contribute to the development/improvement of submission templates and authoring guides.
- 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/Requirements:
- PhD, MS, or other university degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth and superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
- Knowledge of regulatory documents for product development milestones, agency consultation meetings, site inspections, and written responses to agency information requests.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
Skills (Required/Preferred):
- Leadership to lead cross-functional/internal-external teams.
- Facilitator skills to resolve issues and move projects forward.
- Familiarity with at least one synthetics CMC area: Chemistry; drug product development (formulation & manufacturing); Analytical development; process and method validations.
- Agility with digital-first environments; embrace AI/ML and digital transformation.
- Proficiency in Vault RIM, Word, and Adobe.
Nice to have:
- Agile/Scrum experience; data integration platforms.
- Knowledge of AI/ML, 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:
- Not specified in the provided text.
- 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 a 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 health authority information requests.
- Ensure consistent information throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between dossiers.
- Contribute to the development/improvement of submission templates and authoring guides.
- 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/Requirements:
- PhD, MS, or other university degree in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
- In-depth and superior knowledge in pharmaceutical development (mandatory).
- Minimum 5 years of professional experience in CMC development.
- Proven track record in authoring CMC dossiers.
- Knowledge of regulatory documents for product development milestones, agency consultation meetings, site inspections, and written responses to agency information requests.
- Knowledge of CMC dossier structures for clinical trial and market authorization submissions.
Skills (Required/Preferred):
- Leadership to lead cross-functional/internal-external teams.
- Facilitator skills to resolve issues and move projects forward.
- Familiarity with at least one synthetics CMC area: Chemistry; drug product development (formulation & manufacturing); Analytical development; process and method validations.
- Agility with digital-first environments; embrace AI/ML and digital transformation.
- Proficiency in Vault RIM, Word, and Adobe.
Nice to have:
- Agile/Scrum experience; data integration platforms.
- Knowledge of AI/ML, 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:
- Not specified in the provided text.