Director - Regulatory CMC

Responsibilities:
- Independently develop and lead execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.
- Represent and contribute to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- Provide leadership and expert understanding of GRA CMC regulations and guidelines; adapt strategy to enhance probability of regulatory success and compliance.
- Use strong analytical/process understanding to develop robust, accurate submissions.
- Build constructive relationships and proactively communicate issues with internal/external colleagues, including Alliance Partners.
- Communicate and negotiate with Health Authorities (directly and indirectly).
- Apply expert GRA CMC knowledge to address challenges during development and commercialization.
- Mentor/coaches GRA CMC members as required.
- Develop, execute, and oversee regulatory submissions preparation per GRA CMC Product Team strategy; define and drive CMC dossier content and review for conformance.
- Represent Takeda GRA CMC in Health Authority meetings and drive CMC meeting preparation.
- Provide guidance on administrative procedural topics with International Health Authorities as required.
- Provide strategic input into change control evaluation; ensure regulatory compliance.
- Keep stakeholders informed of developments impacting regulatory success; use sound judgment in timely communication.
- Review and provide CMC regulatory input/approvals for technical protocols and reports to ensure alignment with global regulatory requirements.
- Prepare/maintain regulatory documentation (e.g., technical regulatory strategies, storyboards, risk assessments) and provide tactical regulatory guidance in line with global strategies.
- Lead assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
- Provide global regulatory input/support for change controls, deviations, investigations; work effectively in a complex matrix environment.
- Support development of strategies/tools/trainings to advance the GRA CMC roadmap.

Qualifications/Requirements:
- BS/BA in a scientific discipline; advanced degree (MS/PhD) required.
- 10+ years biopharmaceutical/device industry experience; 8+ years pharmaceutical Regulatory CMC and/or devices experience, including leading major submissions during LCM/development (including NDA/NLA/MAA).
- Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development/registration/post-market support teams.
- Strong attention to detail; ability to assess alternative approaches; base strategy on precedents/regulatory intelligence plus regulations/guidelines.
- Ability to handle critical issues with minimal oversight; exercise good judgment and elevate issues to line management.
- Excellent written and oral communication skills.

Skills:
- Leadership, emerging leadership, problem-solving, flexibility, and teamwork; inclusive culture; prioritization with limited support.