Akebia Therapeutics · 3 days ago
Sr. Director, Regulatory Affairs
Cambridge, MA
Full-time
Onsite
Director/Executive
$246K/yr - $304K/yr
8+ years expAkebia Therapeutics is focused on bettering the lives of individuals impacted by kidney disease. They are seeking a Senior Director, Regulatory Affairs to develop regulatory strategies and lead submissions for their therapeutic products in chronic kidney disease.
BiotechnologyHealth CareTherapeutics
Responsibilities
Design and support implementation of well-informed global regulatory strategies
Represent Regulatory Affairs on project sub-teams (e.g., Product Team, Clinical Team, etc.) and provide regulatory strategy and guidance (e.g. protocol reviews, report reviews, development plans)
Liaise with and lead the preparation, as well as meetings with Regulatory Health Authorities (e.g. U.S., E.U, Japan)
Lead the coordination, preparation and timely submission of regulatory documents (e.g. briefing documents, pediatric plans, INDs, NDAs)
Manage, mentor, and develop direct reports, who may lead their own development programs
Write regulatory documents (e.g. pediatric plans, briefing documents) to support regulatory agency submissions
Establish relevant processes and procedures to support the Regulatory Affairs function activities
Maintain knowledge of US, EU and ROW regulatory requirements and ensure compliance with regulatory requirements
Articulate complex issues and strategic recommendations concisely and effectively across all stakeholders including senior leaders
Develop approaches and solutions to achieve business critical goals and/or mitigate risks
Qualification
Required
Bachelor's degree in life sciences required; advanced degree preferred
Minimum of 8 years pharmaceutical industry experience with a minimum of 6 years in Regulatory Affairs
Evidence of successful submissions to FDA and EMA (e.g. IND, NDA, MAA, briefing packages)
Experience managing and developing direct reports
Demonstrated evidence of writing regulatory documents (pediatric plans, Module 1, Module 2, briefing packages)
Knowledge of US and EU regulatory requirements
Knowledge of drug development
Excellent written and oral communication skills
Excellent interpersonal skills
Strong project management skills and drive for excellence
Preferred
Previous experience working for FDA is a plus
Benefits
Health care
Vision
Dental
Retirement
PTO
Company
Akebia Therapeutics
Akebia Therapeutics develops treatments for ischemia and vascular diseases.
201-500 employees
H1B Sponsorship
Akebia Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (5)
2023 (3)
2022 (12)
2021 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$442.5M2024-01-30Post Ipo Debt· $37M
2020-05-11Post Ipo Equity· $151.8M
2019-11-12Post Ipo Debt· $100M
Leadership Team
John Butler
President and CEO
Erik Ostrowski
CBO & CFO
Recent News
2026-01-12
Labiotech UG
2026-01-08
MarketScreener
2026-01-06
Company data provided by crunchbase