Global Regulatory CMC Leader — Hybrid Strategic Submissions

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

Benefits offered by this job

Hybrid work model

Job summary

Takeda Pharmaceutical Company Limited in Boston, MA, is seeking an accomplished Regulatory CMC leader to drive global submissions and strategy across development and lifecycle, with strong leadership and communication skills.

The role requires 10+ years in biopharmaceutical Regulatory CMC and/or devices, with experience guiding NDA/BLA/MAA submissions and cross-functional teams in a hybrid work environment. Mentors teams and partners with Health Authorities globally.

Qualifications

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D.) required.
• 10+ years of biopharmaceutical/regulatory CMC and/or devices experience.
• Experience leading major submissions (NDA/BLA/MAA) during lifecycle.
• Strong understanding of global CMC regulatory requirements and guidelines.

Responsibilities

• Develops and leads global regulatory CMC strategy for assigned products.
• Represents regulatory CMC in health authority meetings and cross-functional teams.
• Mentors GRA CMC members and drives timely regulatory submissions.
• Ensure regulatory compliance and proactive risk management across programs.

Skills

Regulatory CMC leadership

Leadership

Communication skills

Analytical thinking

Regulatory strategy

Education

BS/BA in science

MS/PhD preferred

Job description

Takeda Pharmaceutical Company Limited in Boston, MA, is seeking an accomplished Regulatory CMC leader to drive global submissions and strategy across development and lifecycle, with strong leadership and communication skills.

The role requires 10+ years in biopharmaceutical Regulatory CMC and/or devices, with experience guiding NDA/BLA/MAA submissions and cross-functional teams in a hybrid work environment. Mentors teams and partners with Health Authorities globally.