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Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

Akebia TherapeuticsCambridge, MA, United States
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Sr. Director, Regulatory Affairs

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Regulatory Affairs

Cambridge, MA

ID : 25A-15

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, a ll 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.

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    Director Regulatory • Cambridge, MA, United States

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