Global Regulatory CMC Director: Strategy & Submissions

Regulatory Jobs; Boston (MA); Híbrido; USD 177.000 - 278.000; Jornada completa

Descripción de la vacante

Takeda is seeking a Senior Regulatory CMC Leader to oversee regulatory submissions for GRA CMC products, guiding content strategy and reviews to meet global requirements. The role involves representing GRA CMC in Health Authority meetings, mentoring team members, and ensuring regulatory compliance across development and lifecycle activities.

The position requires a strong track record in NDA/MAA submissions, cross-functional collaboration, and excellent communication skills to drive successful

Formación

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/NLA/MAA.
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Excellent written and oral communication skills required.

Responsabilidades

• Develops regulatory submissions preparation per the GRA CMC Product Team strategy.
• Guide the team to define and drive strategy for CMC regulatory dossier content and reviews for conformance with established requirement.
• Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.
• Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.
• Mentors GRA CMC members and supports development of strategies, tools, and trainings to advance the GRA CMC roadmap.
• Proactively communicates CMC regulatory strategies, risks and issues to cross-functional teams and management.

Conocimientos

Regulatory leadership

Regulatory communication

CMC regulatory knowledge

Leadership

Cross-functional collaboration

Educación

BS/BA in a scientific discipline

Advanced degree (M.S./Ph.D.)

Descripción del empleo

Takeda is seeking a Senior Regulatory CMC Leader to oversee regulatory submissions for GRA CMC products, guiding content strategy and reviews to meet global requirements. The role involves representing GRA CMC in Health Authority meetings, mentoring team members, and ensuring regulatory compliance across development and lifecycle activities.

The position requires a strong track record in NDA/MAA submissions, cross-functional collaboration, and excellent communication skills to drive successful