CMC dossier leader

Main Responsibilities:
- Lead, coordinate, and manage CMC dossier preparation and development processes.
- Align dossier strategy with CMC activities to support expedited pathways to clinic and patients.
- Lead CMC dossier sub-teams (Dossier Subgroup/Submission Taskforce) for authoring, review, comment resolution, and approval.
- Ensure timely regulatory submission delivery (IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA; health authority information requests).
- Maintain consistent information across CMC dossier sections and with other modules (e.g., clinical/preclinical).
- Improve submission templates and authoring guides with CMC functions, GRA CMC, and Digital teams.
- Support M&A/licensing diligence by assessing CMC dossier content.
- Drive AI-powered solutions and digital tools to transform CMC regulatory document preparation.

Qualifications & Required Skills:
- PhD/MS or relevant university degree (pharmaceutical chemistry, pharmacy, biochemistry, etc.).
- In-depth, superior knowledge in pharmaceutical development.
- 5+ years CMC development experience; proven CMC dossier authoring track record.
- Knowledge of synthetics CMC (at least one): chemistry, drug product development, analytical development, or process/method validation.
- Strong understanding of regulatory documents and CMC structures for clinical/market submissions.
- Leadership to manage cross-functional partners; strong facilitator/problem-solving skills.
- Ability to work in digital-first environments; proficiency with Vault RIM, Word, and Adobe.
- Comfort with AI/ML and digital transformation.

Nice to have:
- Agile/Scrum experience, data integration platforms, digital QMS/electronic batch records.

Benefits (if offered):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks gender-neutral parental leave.