CMC Dossier Leader

Role Summary

CMC Dossier Leader - AI transformation Champion. Location: Framingham, MA / Waltham, MA. You will lead the preparation and management of CMC dossiers for regulatory submissions, leveraging AI-powered tools to transform how we prepare and manage CMC dossiers, and drive alignment between dossier strategy and CMC activities.

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
• Languages: Excellent oral and written English communication skills

Skills

• Agility to embrace digital transformation and AI/ML applications
• Knowledge of at least one aspect of CMC development for Biologics: Cell line development, Formulation, DS/DP aseptic manufacturing, Analytical development, and Process and Method validations
• Comfortable working in digital-first environments with ability to quickly adopt new technologies
• Understanding of regulatory documents required to support product development milestones, consultation meetings with agency, site inspections, or written responses to Agency’s information requests
• Knowledge of CMC dossier structures required for clinical trial and market authorization submissions
• Leadership capabilities: Ability to lead cross-functional teams with internal and/or external partners
• Strong team spirit with assertiveness: Ability to represent CMC Dossier Sciences and contribute to cross-company projects
• Facilitator skill to resolve issues and move project forward
• Agility in priorities, readiness to adopt a TRT culture and embrace continuous digital innovation
• Proficiency in leveraging with digital tools (e.g., Vault RIM, Word and adobe)
• 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