CMC Dossier Leader

Role Summary

CMC Dossier Leader - AI transformation Champion, based in Framingham, MA or Waltham, MA. Lead AI-enabled transformation of CMC dossier preparation and regulatory submissions within the CMC Dossier Sciences team to accelerate product development. Drive cross-functional collaboration and leverage digital tools to streamline dossier content and delivery to regulators.

Responsibilities

• Drive AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents
• Lead, coordinate, and manage CMC dossier preparation and development processes.
• Drive alignment between dossier strategy and CMC activities as a core CMC team member, ensuring data supports expedited pathways to clinic and patients
• Lead CMC sub team (Dossier Subgroup or Submission Taskforce) for authoring, review, comment resolution, and approval of CMC dossiers
• Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from Health Authorities).
• Ensure consistent information presented throughout CMC dossiers and with other modules (e.g., clinical and preclinical) and between CMC dossiers
• Contribute to the elaboration/improvement of the submission templates and authoring guides in close collaboration with CMC functions, GRA CMC and Digital teams.
• Support M&A, in licensing due diligence activities by assessing the CMC dossiers content

Qualifications

• Required: 5+ years of professional experience in CMC development
• Required: Proven track record in authoring CMC dossiers
• Required: Understanding of current pharmaceutical environment including digital transformation, economic and regulatory challenges
• Preferred: Experience working with agile/scrum methodologies in pharmaceutical development
• Preferred: CMC knowledge and experience in Cell/Gene Therapeutics
• Preferred: Experience with data integration platforms
• Preferred: Understanding of AI/ML applications in pharmaceutical development
• Preferred: Knowledge of digital quality management systems and electronic batch records
• Required: Excellent oral and written English communication skills

Skills

• Advanced expertise in AI-powered tools for document intelligence and automation
• Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs
• Skilled in AI applications and prompt engineering
• Organization skill for planning, time management, and communication
• Constantly question and challenge status-quo and propose new digitally-enabled ways of working
• Ability to anticipate, prevent and resolve CMC dossier challenges by thinking out of the box
• Champion of digital transformation initiatives within the CMC community

Education

• MS or PhD or an equivalent level degree in life sciences in one of the areas of biopharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry or related degree)
• In depth and superior knowledge in pharmaceutical development is mandatory