Senior Manager, Global Regulatory Affairs CMC
Takeda
August 25, 2026
Remote friendly (Boston, MA)
United States
$137,000 - $215,270 USD yearly
Corporate Functions
Responsibilities
- With some supervision, lead execution of regulatory Chemistry, Manufacturing & Controls (CMC) investigational, registration, and/or post-approval strategies for assigned products.
- Serve as RA CMC delegate for the GRA CMC Product Lead across clinical development and commercial lifecycle.
- Apply global RA CMC regulations and guidelines to enhance regulatory success and compliance.
- Use precedents and regulatory intelligence to support robust, accurate submissions.
- Plan, execute, and manage regulatory submissions per the strategy from GRA CMC Product/Device leads.
- Define CMC content (data/documentation) requirements and review for conformance; anticipate future challenges.
- Support CMC preparation for meetings with Health Authorities.
- Interact with international Health Authorities on administrative procedural topics.
- Evaluate change proposals for global regulatory impact; ensure and enhance regulatory compliance.
- Communicate developments impacting regulatory success to stakeholders; exercise sound judgment and timely escalation.
Qualifications
- BS/BA in a scientific discipline; advanced degree preferred.
- 6+ years pharmaceutical Regulatory CMC or Device experience, including major variation/amendment leadership and/or support for initial IND/IMPD or initial NDA/BLA (equivalent industry experience considered).
- Strong understanding of scientific principles and global regulatory CMC requirements (drug development and post-market support).
- Proven ability to understand/communicate regulatory strategy; analytical attention to detail; assess alternative approaches.
- Excellent written and oral communication; emerging leadership and teamwork; inclusive culture.
Benefits
- Medical, dental, vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation are mentioned.
Application instructions
- Apply via the “Apply” button (acknowledging privacy notice/terms of use and that submitted information is accurate).
- With some supervision, lead execution of regulatory Chemistry, Manufacturing & Controls (CMC) investigational, registration, and/or post-approval strategies for assigned products.
- Serve as RA CMC delegate for the GRA CMC Product Lead across clinical development and commercial lifecycle.
- Apply global RA CMC regulations and guidelines to enhance regulatory success and compliance.
- Use precedents and regulatory intelligence to support robust, accurate submissions.
- Plan, execute, and manage regulatory submissions per the strategy from GRA CMC Product/Device leads.
- Define CMC content (data/documentation) requirements and review for conformance; anticipate future challenges.
- Support CMC preparation for meetings with Health Authorities.
- Interact with international Health Authorities on administrative procedural topics.
- Evaluate change proposals for global regulatory impact; ensure and enhance regulatory compliance.
- Communicate developments impacting regulatory success to stakeholders; exercise sound judgment and timely escalation.
Qualifications
- BS/BA in a scientific discipline; advanced degree preferred.
- 6+ years pharmaceutical Regulatory CMC or Device experience, including major variation/amendment leadership and/or support for initial IND/IMPD or initial NDA/BLA (equivalent industry experience considered).
- Strong understanding of scientific principles and global regulatory CMC requirements (drug development and post-market support).
- Proven ability to understand/communicate regulatory strategy; analytical attention to detail; assess alternative approaches.
- Excellent written and oral communication; emerging leadership and teamwork; inclusive culture.
Benefits
- Medical, dental, vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation are mentioned.
Application instructions
- Apply via the “Apply” button (acknowledging privacy notice/terms of use and that submitted information is accurate).