GRA CMC Director — Regulatory Strategy & Submissions

Takeda; Boston (MA); Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Regulatory CMC Product Lead to independently develop and lead regulatory strategies for investigational, registration and post-approval activities. You will represent GRA CMC in cross-functional teams and in Health Authority engagements, ensuring regulatory success and compliance.

You will mentor team members and apply expert GRA CMC knowledge to address challenges across development and commercialization.

Qualifications

• BS/BA in a Scientific Discipline is required.
• Advanced Degree (M.S., Ph.D., etc.) is required.
• 8+ years pharma Regulatory CMC and/or devices experience is expected.
• 10+ years biopharmaceutical/device industry experience overall.
• Proven ability to lead major submissions during NDA/MAA lifecycle.

Responsibilities

• Develops and leads regulatory CMC investigational, registration and post-approval strategies as GRA CMC Product Lead.
• Represents Regulatory, Pharmaceutical Development, and Commercial teams.
• Communicates and negotiates with Health Authorities.
• Mentors GRA CMC members and fosters teamwork.
• Drives global regulatory submissions through product lifecycle.

Skills

Regulatory CMC

Leadership

Health Authority liaison

Regulatory strategy

Analytical skills

Cross-functional collaboration

Mentoring

Education

BS/BA in scientific discipline

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

Job description

Takeda is seeking a Regulatory CMC Product Lead to independently develop and lead regulatory strategies for investigational, registration and post-approval activities. You will represent GRA CMC in cross-functional teams and in Health Authority engagements, ensuring regulatory success and compliance.

You will mentor team members and apply expert GRA CMC knowledge to address challenges across development and commercialization.