Sr. Director, Regulatory Affairs
Company: Akebia Therapeutics
Location: Cambridge
Posted on: June 2, 2025
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Job Description:
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Regulatory Affairs
Cambridge, MA
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ID:
25A-15
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Full-Time/Regular
Nearly 37 million Americans are currently affected by Chronic
Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come
to work, with the purpose of bettering the lives of each person
impacted by kidney disease and the renal community that serves
them.
Our tenacious, passionate employees' challenge the status quo and
work to develop unique therapeutics that have the potential to set
new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
Job Summary:
Akebia is currently expanding its Regulatory team to support early
and late-stage assets and is searching for a Senior Director,
Regulatory Affairs to 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 individual will operate in a high visibility role and
will be responsible for developing and coordinating regulatory
strategies and leading IND/CTA and sNDA/NDA preparation and
submissions to regulatory agencies. This position reports to the
Vice President, Regulatory Affairs.
Essential Functions & Duties
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
Skills & Experience
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
Previous experience working for FDA is a plus
Compensation:
Targeted Base: $246,330 - $304,290*
*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. Akebian's aren't afraid of diving in and owning a
process or a problem, because we all want to deliver a great
solution. Akebian's 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
characteristics protected by applicable law.
Keywords: Akebia Therapeutics, Boston , Sr. Director, Regulatory Affairs, Executive , Cambridge, Massachusetts
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