CMC dossier leader

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; and health authority information requests).
• Ensure consistent information across CMC dossiers and other modules (e.g., clinical and preclinical), and between dossiers.
• Contribute to improving 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 preparation of CMC regulatory documents.

• PhD, MS, or other university degrees in pharmaceutical drug development (e.g., pharmaceutical chemistry, pharmacy, biochemistry).
• In-depth and superior knowledge in pharmaceutical development (mandatory).
• Minimum 5 years’ professional experience in CMC development.
• Proven track record in authoring CMC dossiers.
• Understanding of pharmaceutical environment, including digital transformation, economic, and regulatory challenges.
• Ability to embrace digital transformation and AI/ML applications.
• Knowledge of at least one synthetics CMC area:
  Chemistry;
  Drug product development (formulation & manufacturing);
  Analytical development;
  Process and Method validations.
• Comfort working in digital-first environments and adopting new technologies.
• 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 and cross-functional collaboration with internal/external partners.
• Issue-resolution and facilitation skills.
• Proficiency in Vault RIM, Word, and Adobe.

• Experience with agile/scrum.
• Experience with data integration platforms.
• Knowledge of digital quality management systems and electronic batch records.

• Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.