Site CMC Regulatory Director — Post-Approval Strategy

Takeda; Boston (MA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and aligning with global regulatory expectations. You will apply ICH Q12 principles, drive standardized processes, and explore automation to improve predictability and efficiency in regulatory activities.

You will communicate regulatory strategy to drug development, registration, and post‑market teams, leveraging strong leadership and collaboration

Qualifikationen

• BS/BA Degree in a Scientific Discipline; Advanced Degree (M.S., Ph.D., etc.) preferred.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required.
• Strong practical experience with global HA requirements, beyond EU/US.
• 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.
• Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
• Applies directions taken by the company and escalates issues as necessary.
• Demonstrates leadership, problem‑solving ability, flexibility and teamwork; promotes an inclusive culture.
• Excellent written and oral communication skills; demonstrated leadership and collaboration skills.

Aufgaben

• Lead site‑specific post‑approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes).
• Apply science‑ and risk‑based approaches, guided by ICH Q12 principles, to assess and implement post‑approval changes.
• Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site‑based regulatory activities.
• Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
• Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
• Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
• Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
• Facilitate alignment between site teams and global Regulatory CMC on post‑approval strategies and activities and represent global Regulatory CMC in cross‑functional Change Review meetings.
• Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
• Promote sustainable practices and scalability in site‑level regulatory operations.

Kenntnisse

Leadership

Communication

Collaboration

Negotiation

Problem solving

Teamwork

Prioritization

Inclusive culture

Ausbildung

BS/BA in Scientific Discipline

MS/PhD preferred

Jobbeschreibung

Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and aligning with global regulatory expectations. You will apply ICH Q12 principles, drive standardized processes, and explore automation to improve predictability and efficiency in regulatory activities.

You will communicate regulatory strategy to drug development, registration, and post‑market teams, leveraging strong leadership and collaboration