Associate Director, Global Regulatory CMC — Hybrid Leader

Regulatory Jobs; Boston (MA); Hybride; USD 154 000 - 243 000; Plein temps

Avantages offerts par ce poste

Hybrid work policy

Base salary range

Résumé du poste

Takeda's Global Regulatory Affairs CMC team seeks an experienced professional to develop and execute regulatory CMC strategies for assigned products throughout development and lifecycle. You will lead submissions, define content, and collaborate with Health Authorities in a matrix environment.

This role requires deep global CMC knowledge, strong regulatory leadership, and the ability to align product teams with regulatory strategies. Hybrid work model in Boston, MA.

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 10+ years in biopharmaceutical/device with 5+ years Regulatory CMC or Device experience.
• Strong regulatory CMC knowledge for global drug development and post-market support.
• Proven ability to communicate regulatory strategy to cross-functional teams.
• Attention to detail in issue analysis and prioritization of regulatory actions.

Responsabilités

• Develops and leads execution of regulatory CMC strategies for assigned products.
• Defines CMC content requirements for submissions and ensures conformance.
• Represents Takeda RA CMC in Health Authority meetings when needed.
• Interacts with international Health Authorities on procedural topics.
• Reviews regulatory CMC input for protocols, reports, and regulatory documents.
• Leads or supports global regulatory submissions through product lifecycle.

Connaissances

Regulatory CMC leadership

Global RA CMC knowledge

Health Authority negotiation

Regulatory submissions planning

Cross-functional communication

Formation

BS/BA in scientific discipline

Advanced degree preferred

Description du poste

Takeda's Global Regulatory Affairs CMC team seeks an experienced professional to develop and execute regulatory CMC strategies for assigned products throughout development and lifecycle. You will lead submissions, define content, and collaborate with Health Authorities in a matrix environment.

This role requires deep global CMC knowledge, strong regulatory leadership, and the ability to align product teams with regulatory strategies. Hybrid work model in Boston, MA.