Manager Regulatory Affairs, CMC
Akebia Therapeutics
June 26, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Job Summary
- Manager, Regulatory Affairs CMC supporting development of vadadustat for anemia and other pipeline products; reports to the Sr. Director, Regulatory Affairs CMC.
Essential Functions and Duties
Strategy:
- Implement global CMC strategy for assigned programs.
- Collaborate with cross-functional teams to assess regulatory impact on CMC-related issues.
- Lead CMC-focused regulatory projects.
- Understand regulatory risk and phase-appropriate approaches.
Authoring and Submission Excellence:
- Author and compile CMC modules for INDs/IMPDs/CTAs; NDAs/BLAs/MAAs; amendments, supplements, and variations.
- Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality to ensure high-quality submissions using Regulatory eCTD templates.
- Support global submissions, amendments, supplements, and responses to health authority information requests.
- Evaluate change controls for CMC impact across company-owned filings.
Lifecycle & Change Management:
- Support regulatory assessments of CMC changes, deviations, and CAPAs.
- Oversee timely execution of variations and supplements across regions.
Process Building:
- Implement review, approval, and submission processes.
- Maintain regulatory tracking tools and data.
- Contribute to SOP development and regulatory process documentation.
Basic Qualifications:
- Bachelor’s degree in life sciences (advanced degree preferred).
- 5+ years Regulatory Affairs CMC experience in pharma/biotech.
- Experience with global FDA/EMA submissions (e.g., IND, NDA, MAA, briefing packages).
- Regulatory information management system experience (e.g., Veeva RIM preferred).
- Strong project management; ability to author CMC documents; manage cross-functional inputs.
- Strong understanding of US/EU regulatory requirements.
- Knowledge of drug development for small molecules and biologics.
- Excellent written/oral communication and interpersonal skills.
Compensation:
- Targeted base: $139,672–172,536. Base pay may vary; additional benefits include health care, vision, dental, retirement, PTO, etc.
- Manager, Regulatory Affairs CMC supporting development of vadadustat for anemia and other pipeline products; reports to the Sr. Director, Regulatory Affairs CMC.
Essential Functions and Duties
Strategy:
- Implement global CMC strategy for assigned programs.
- Collaborate with cross-functional teams to assess regulatory impact on CMC-related issues.
- Lead CMC-focused regulatory projects.
- Understand regulatory risk and phase-appropriate approaches.
Authoring and Submission Excellence:
- Author and compile CMC modules for INDs/IMPDs/CTAs; NDAs/BLAs/MAAs; amendments, supplements, and variations.
- Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality to ensure high-quality submissions using Regulatory eCTD templates.
- Support global submissions, amendments, supplements, and responses to health authority information requests.
- Evaluate change controls for CMC impact across company-owned filings.
Lifecycle & Change Management:
- Support regulatory assessments of CMC changes, deviations, and CAPAs.
- Oversee timely execution of variations and supplements across regions.
Process Building:
- Implement review, approval, and submission processes.
- Maintain regulatory tracking tools and data.
- Contribute to SOP development and regulatory process documentation.
Basic Qualifications:
- Bachelor’s degree in life sciences (advanced degree preferred).
- 5+ years Regulatory Affairs CMC experience in pharma/biotech.
- Experience with global FDA/EMA submissions (e.g., IND, NDA, MAA, briefing packages).
- Regulatory information management system experience (e.g., Veeva RIM preferred).
- Strong project management; ability to author CMC documents; manage cross-functional inputs.
- Strong understanding of US/EU regulatory requirements.
- Knowledge of drug development for small molecules and biologics.
- Excellent written/oral communication and interpersonal skills.
Compensation:
- Targeted base: $139,672–172,536. Base pay may vary; additional benefits include health care, vision, dental, retirement, PTO, etc.