Akebia Therapeutics · 4 days ago
VP, Regulatory Affairs
Cambridge, MA
Full-time
Onsite
Director/Executive
$308K/yr - $380K/yr
10+ years expAkebia Therapeutics is focused on developing unique therapeutics to improve the lives of those affected by Chronic Kidney Disease. The VP of Regulatory Affairs will lead the regulatory strategy for product development and ensure compliance for successful global regulatory approval.
BiotechnologyHealth CareTherapeutics
Responsibilities
Formulate and oversee implementation of regulatory strategy and activities needed to secure approval of Akebia’s products
Manage coordination, preparation and timely submission of regulatory documents (e.g., INDs, MAAs, NDAs)
Author, review and critique documents that will be included in regulatory applications and interactions
Foster strong relationships and advocacy with FDA and international regulatory authorities as well as ensuring strong coordination and collaboration across internal functional and stakeholders
Maintain expert knowledge of, and familiarity with, FDA/EMA regulations and ICH guidelines
Provide clear and valid regulatory guidance and direction to other departments and project teams
Represent regulatory strategy at project team meetings and provide regulatory support for projects which may include clinical, preclinical, CMC and marketing issues
Develop and maintain relationships with external vendors and health care regulatory authorities
Manage all activities pertaining to interactions with FDA, and other health care regulatory authorities, and communicate outcomes to senior management
Supervise team members and consultants to the Regulatory Affairs department
Develop and implement standard operating procedures and common work practices within the team
Host FDA/third party regulatory audits and ensure follow up on findings/observations issued
Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities
Qualification
Required
10+ years of progressively responsible experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry
Minimum of 3 years of leadership experience in a regulatory affairs management role
Minimum BS degree in a scientific discipline, preferably life sciences or pharmacy
Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA
Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance
Demonstrated expert knowledge of the regulations and practices of FDA, EMA, and other major health care regulatory authorities
Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight
Demonstrated experience in negotiating with and presenting to regulatory agencies such as FDA
Strong consulting and analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions
Demonstrated management expertise, including the leadership and professional development of the Regulatory team
A hands-on leader who leads by example as well as willingness to roll-up sleeves and draft sections for regulatory submissions
Demonstrated ability to work independently with exceptional organization and attention to detail
Excellent oral and written communication and presentation skills
Ability to work well under pressure and adhere to deadlines
Preferred
Regulatory certification (RAC) a plus
An advanced degree in the biological sciences (MD, PhD, or PharmD) is desirable
Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable
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