Talent.com
Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

Akebia TherapeuticsCambridge, MA, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Sr. Director, Regulatory Affairs

LinkedIn

Twitter

Email

Message

Share

  • var a2a_config = a2a_config || {};
  • a2a_config.onclick = 1;

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.

    serp_jobs.job_alerts.create_a_job

    Director Regulatory • Cambridge, MA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Associate Director, Protein Analysis

    Associate Director, Protein Analysis

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for an Associate Director, Head Americas Proteins.Key Responsibilities Analyze supply and demand drivers impacting global agricultural markets, focusing on North and South Am...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Director of Product Policy

    Director of Product Policy

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Policy Strategy.Key Responsibilities Lead a global team to develop policy strategies aligning with product goals Serve as a strategic advisor, integrating ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sr. Director, Head of Global Regulatory Labeling Strategy

    Sr. Director, Head of Global Regulatory Labeling Strategy

    ModernaCambridge, MA, US
    serp_jobs.job_card.permanent
    Within an end-to-end (E2E) labeling framework, manage a team of labeling strategy leads responsible for, in partnership with the GRS Strategy team, ensuring the development and implementation of re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    eGenesisCambridge, MA, US
    serp_jobs.job_card.full_time
    Senior Director, Regulatory Affairs.Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Director / Senior Director of Regulatory Affairs is responsible fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Senior Regulatory Strategy Manager

    Senior Regulatory Strategy Manager

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Sr Manager Global Regulatory Strategy to oversee clinical trial activities across multiple programs. Key Responsibilities : Serve as the regulatory affairs lead for clini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Utility Regulatory Director

    Utility Regulatory Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Utility Regulatory Support.Key Responsibilities Act as a steward of regulatory relationships, processes, and deliverables Research and apply findings across ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting GroupBoston, MA, United States
    serp_jobs.job_card.full_time
    Career Opportunities with Halloran Consulting Group.Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will d...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director / Director of Regulatory Affairs

    Senior Director / Director of Regulatory Affairs

    Redefine Your Future with TransMedicsAndover, MA, US
    serp_jobs.job_card.full_time
    Senior Director / Director of Regulatory Affairs.TransMedics' pioneering Organ Care System (OCS) was developed to address the major limitations of the current standard of care, cold storage, by prese...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Oncology Regulatory Affairs Director

    Oncology Regulatory Affairs Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for an Associate Director, Regulatory Affairs (Oncology).Key Responsibilities Manage regional regulatory activities as part of a Global Regulatory Team Lead regulatory activ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Arizona Licensed Privacy Director

    Arizona Licensed Privacy Director

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Privacy Director to lead and manage its privacy program.Key Responsibilities Direct, implement, and maintain compliance programs, policies, and procedures related to pr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sr. Director, Regulatory Affairs Cambridge, MA

    Sr. Director, Regulatory Affairs Cambridge, MA

    AkebiaCambridge, MA, US
    serp_jobs.job_card.full_time
    Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs - Strategy

    Director, Regulatory Affairs - Strategy

    Lantheus BrandBedford, MA, US
    serp_jobs.job_card.full_time
    Director, Regulatory Affairs - Strategy.Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Regulatory Submission Specialist

    Regulatory Submission Specialist

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Regulatory Submission Project Management Specialist.Key Responsibilities Schedule and manage routine regulatory submissions, including IND safety reports and clinical s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs - Strategy

    Director, Regulatory Affairs - Strategy

    LantheusBedford, MA, United States
    serp_jobs.job_card.full_time
    Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has help...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    US Regulatory Policy Director

    US Regulatory Policy Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities : Lead the acquisition, analysis, communication, and knowledge management of US regulatory in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Director of R&D

    Director of R&D

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of R&D.Key Responsibilities Develop and execute the company's long-term R&D and innovation strategy Oversee the entire product development lifecycle from conc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Senior Manager / Associate Director, Regulatory Strategy

    Senior Manager / Associate Director, Regulatory Strategy

    EyePointWatertown, MA, US
    serp_jobs.job_card.full_time
    Be Seen And Heard At Eyepoint Pharmaceuticals.At EyePoint, leadership trusts our employees to get the job done.The patient-centric and award-winning approach we're taking in business fuels our succ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory CMC

    Senior Director, Regulatory CMC

    PepGenBoston, MA, US
    serp_jobs.job_card.full_time
    PepGen is at an exciting time in our development.This role is for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape our future.As an int...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day