Associate Director, Global Regulatory Affairs CMC
Takeda
9 hours ago
Remote friendly (Boston, MA)
United States
$154,400 - $242,550 USD yearly
Operations
Responsibilities:
- With minimal supervision, develop and lead execution of regulatory CMC investigational, registration, and/or post-approval strategies for assigned products.
- Serve as RA CMC member on the Global Regulatory CMC team; may act as delegate for the GRA CMC Product Lead across clinical and commercial lifecycle.
- Develop, plan, execute, and manage regulatory submissions per GRA CMC Product Team technical regulatory strategy.
- Independently define CMC content (data and documentation) requirements for regulatory submissions; ensure conformance to established requirements.
- Represent Takeda RA CMC in Health Authority meetings (with supervision) and support CMC preparation activities.
- Interact with international Health Authorities on administrative procedural topics, as required.
- Evaluate change proposals for global regulatory impact; ensure regulatory compliance with HA regulations and conformance with Takeda controlled procedures and GRA CMC best practices.
- Keep project teams and stakeholders apprised of developments impacting regulatory success; communicate issues professionally and timely.
- Review/provide regulatory CMC input and approve technical protocols/reports as needed.
- In a GRA CMC Product Team lead role, prepare/maintain regulatory documentation (e.g., technical regulatory strategy, storyboards, risk assessments) and provide tactical regulatory guidance; accountable for approvals/meeting targets.
- Support and/or lead global regulatory submissions (Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
- Work effectively in a complex matrix environment; proactively communicate strategies, issues, risks through assigned programs/products and LCM.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/Ph.D. preferred.
- 10+ years biopharmaceutical/device industry experience with 5+ years regulatory CMC or device experience, including leading major variation/amendment; and/or supporting initial IND/IMPD or initial NDA/BLA. Equivalent experience may be considered.
- Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development/registration/post-market support teams.
- Strong analytical skills and attention to detail.
- Base recommendations on precedents/regulatory intelligence, regulations, and guidelines.
- Ability to handle critical issues with minimal supervision; good judgment and proper escalation.
- Understand decision ownership and apply company decisions.
- Emerging leadership, problem-solving, flexibility, and teamwork; promotes inclusive culture.
- Excellent written and oral communication skills.
Application instructions:
- Apply via the company application process (acknowledge that information will be processed per Takeda’s Privacy Notice and Terms of Use).
- With minimal supervision, develop and lead execution of regulatory CMC investigational, registration, and/or post-approval strategies for assigned products.
- Serve as RA CMC member on the Global Regulatory CMC team; may act as delegate for the GRA CMC Product Lead across clinical and commercial lifecycle.
- Develop, plan, execute, and manage regulatory submissions per GRA CMC Product Team technical regulatory strategy.
- Independently define CMC content (data and documentation) requirements for regulatory submissions; ensure conformance to established requirements.
- Represent Takeda RA CMC in Health Authority meetings (with supervision) and support CMC preparation activities.
- Interact with international Health Authorities on administrative procedural topics, as required.
- Evaluate change proposals for global regulatory impact; ensure regulatory compliance with HA regulations and conformance with Takeda controlled procedures and GRA CMC best practices.
- Keep project teams and stakeholders apprised of developments impacting regulatory success; communicate issues professionally and timely.
- Review/provide regulatory CMC input and approve technical protocols/reports as needed.
- In a GRA CMC Product Team lead role, prepare/maintain regulatory documentation (e.g., technical regulatory strategy, storyboards, risk assessments) and provide tactical regulatory guidance; accountable for approvals/meeting targets.
- Support and/or lead global regulatory submissions (Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
- Work effectively in a complex matrix environment; proactively communicate strategies, issues, risks through assigned programs/products and LCM.
Minimum Requirements/Qualifications:
- BS/BA in a scientific discipline; MS/Ph.D. preferred.
- 10+ years biopharmaceutical/device industry experience with 5+ years regulatory CMC or device experience, including leading major variation/amendment; and/or supporting initial IND/IMPD or initial NDA/BLA. Equivalent experience may be considered.
- Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development/registration/post-market support teams.
- Strong analytical skills and attention to detail.
- Base recommendations on precedents/regulatory intelligence, regulations, and guidelines.
- Ability to handle critical issues with minimal supervision; good judgment and proper escalation.
- Understand decision ownership and apply company decisions.
- Emerging leadership, problem-solving, flexibility, and teamwork; promotes inclusive culture.
- Excellent written and oral communication skills.
Application instructions:
- Apply via the company application process (acknowledge that information will be processed per Takeda’s Privacy Notice and Terms of Use).