Takeda
Overview
At Takeda, the Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post‑approval activities at the site level. This position supports diverse modalities—including small molecules, biologics, and external manufacturing sites—and employs an agile approach to drive standardization, scalability, and sustainability. Responsibilities
Lead site‑specific post‑approval change management activities, including record evaluations and regulatory submissions, ensuring compliance with global requirements. Apply science‑ and risk‑based approaches, guided by ICH Q12 principles, to assess and implement post‑approval changes. Drive 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. Minimum Qualifications
BS/BA in a Scientific Discipline; advanced degree (MS, PhD, etc.) preferred. 10+ years of biopharmaceutical/device industry experience, with 8+ years of direct Regulatory CMC or Regulatory Device experience, including major variations, IND/IMPD preparation, or NDA/BLA support. 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. Analytical skills, attention to detail, and ability to assess alternative approaches. Ability to develop global regulatory strategy recommendations based on precedents and regulatory intelligence. Sound judgment in elevating and communicating issues to line management. Emerging leadership, problem‑solving ability, flexibility and teamwork. Excellent written and oral communication skills. Strong skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections. Compensation & Benefits
Base salary range: $174,500–$274,230 per year. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are also entitled to up to 80 hours of sick time and new hires accrue up to 120 hours of paid vacation. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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At Takeda, the Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post‑approval activities at the site level. This position supports diverse modalities—including small molecules, biologics, and external manufacturing sites—and employs an agile approach to drive standardization, scalability, and sustainability. Responsibilities
Lead site‑specific post‑approval change management activities, including record evaluations and regulatory submissions, ensuring compliance with global requirements. Apply science‑ and risk‑based approaches, guided by ICH Q12 principles, to assess and implement post‑approval changes. Drive 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. Minimum Qualifications
BS/BA in a Scientific Discipline; advanced degree (MS, PhD, etc.) preferred. 10+ years of biopharmaceutical/device industry experience, with 8+ years of direct Regulatory CMC or Regulatory Device experience, including major variations, IND/IMPD preparation, or NDA/BLA support. 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. Analytical skills, attention to detail, and ability to assess alternative approaches. Ability to develop global regulatory strategy recommendations based on precedents and regulatory intelligence. Sound judgment in elevating and communicating issues to line management. Emerging leadership, problem‑solving ability, flexibility and teamwork. Excellent written and oral communication skills. Strong skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections. Compensation & Benefits
Base salary range: $174,500–$274,230 per year. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are also entitled to up to 80 hours of sick time and new hires accrue up to 120 hours of paid vacation. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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