Manager Regulatory Affairs, CMC Cambridge, MA
Akebia Therapeutics(R), Inc., Cambridge, MA, United States
This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, “magnet not mandate” approach to in‑office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.
Job Summary
Akebia is building a highly collaborative, science‑driven team committed to improving the lives of patients with kidney disease and beyond. As we expand our portfolio across early and late‑stage programs, we are looking for a Manager, Regulatory Affairs CMC who will thrive in a team‑oriented, solutions‑focused environment and is looking to play a visible, hands‑on role in shaping regulatory strategy and execution. This role will support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This is an exciting opportunity to directly influence regulatory outcomes and product success. This position 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 the 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 teams to ensure clear, consistent, and high‑quality submissions using Regulatory eCTD templates.
Support global submission, amendments, supplements, and responses to health authority information requests.
Evaluate change controls for CMC impact across Akebia 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 required; advanced degree preferred.
5+ years Regulatory Affairs CMC experience in the pharmaceutical/biotech industry.
Experience supporting high‑quality, global submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages).
Experience with Regulatory information Management systems (e.g., Veeva RIM preferred).
Strong project management and organizational skills, including coordinating team and managing timelines for regulatory submissions.
Demonstrated ability to author CMC documents and manage cross‑functional inputs.
Strong understanding of US and EU regulatory requirements.
Knowledge of drug development for both small molecule and biologics.
Excellent written and oral communication skills with a collaborative, team‑first mindset.
Excellent interpersonal skills.
Compensation
Targeted Base: $139,672‑172,536*
*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company’s total rewards package; all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebians aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebians believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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Job Summary
Akebia is building a highly collaborative, science‑driven team committed to improving the lives of patients with kidney disease and beyond. As we expand our portfolio across early and late‑stage programs, we are looking for a Manager, Regulatory Affairs CMC who will thrive in a team‑oriented, solutions‑focused environment and is looking to play a visible, hands‑on role in shaping regulatory strategy and execution. This role will support the continued development of vadadustat in the treatment of anemia, as well as other pipeline products in chronic kidney disease or other therapeutic indication spaces. This is an exciting opportunity to directly influence regulatory outcomes and product success. This position 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 the 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 teams to ensure clear, consistent, and high‑quality submissions using Regulatory eCTD templates.
Support global submission, amendments, supplements, and responses to health authority information requests.
Evaluate change controls for CMC impact across Akebia 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 required; advanced degree preferred.
5+ years Regulatory Affairs CMC experience in the pharmaceutical/biotech industry.
Experience supporting high‑quality, global submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages).
Experience with Regulatory information Management systems (e.g., Veeva RIM preferred).
Strong project management and organizational skills, including coordinating team and managing timelines for regulatory submissions.
Demonstrated ability to author CMC documents and manage cross‑functional inputs.
Strong understanding of US and EU regulatory requirements.
Knowledge of drug development for both small molecule and biologics.
Excellent written and oral communication skills with a collaborative, team‑first mindset.
Excellent interpersonal skills.
Compensation
Targeted Base: $139,672‑172,536*
*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company’s total rewards package; all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebians aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebians believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
#J-18808-Ljbffr