Talent.com
Associate Director Regulatory Labeling
Associate Director Regulatory LabelingAkebia Therapeutics • Cambridge, MA, United States
Associate Director Regulatory Labeling

Associate Director Regulatory Labeling

Akebia Therapeutics • Cambridge, MA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Associate Director Regulatory Labeling

LinkedIn

Twitter

Email

Message

Share

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

Regulatory Affairs

Cambridge, MA

ID : 25R-26

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

Description : The Associate Director Regulatory Affairs, Labeling is responsible for leading cross functional teams for labeling activities for Akebia products. This role is responsible for ensuring compliance with regulatory agencies requirements and meeting Akebia's strategic labeling objectives. Additional responsibilities include monitoring regulatory compliance trends in industry, interpreting new regulations, guidance documents and enforcement letters. This role is expected to provide support, insight, sound judgment and clear direction on all labeling programs and tactics that are compliant with regulations and company policies. This role reports to the Director Regulatory Affairs, Advertising, Promotion and Labeling.

Responsibilities include but are not limited to the following :

  • Plans and manages USPI and CCDS creation, maintenance, distribution, tracking and implementation to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements.
  • Regulatory lead for the development and lifecycle management of product labeling and artwork (new and revised), with a cross-functional team, ensuring all labeling / artwork is compliant with labeling regulations and Akebia quality standards.
  • Identifies and provides guidance on the development, or improvement, of policies, processes, and standards for labeling activities;
  • Maintains a deep and current awareness of evolving FDA, and key international labeling regulations, advisory comments, enforcement actions and policy issues;
  • Monitors US and key international labeling for competitor updates and keep the organization up-to-date.
  • Responsible for drug listing of original and revised SPLs to support U.S. commercial launch and post-marketing activities.
  • Responsible for the maintenance of SPL software database to track the history and version control of each SPL.
  • Basic Qualifications

  • BA / BS Degree
  • A minimum of 7 years of pharmaceutical industry experience, with at least 3 years of regulatory affairs experience focused labeling for prescription drug products
  • Preferred Qualifications

  • Advanced degree (MS, PhD, PharmD, or JD)
  • Experience with launching new products and / or new indications
  • Strong interpersonal and oral and written communication skills
  • Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate
  • Solid understanding of FDA labeling regulations
  • Demonstrated ability to influence others and foster team collaboration.
  • Strong interpersonal, communication and leadership skills.
  • Forward thinker with strong industry knowledge and ability to identify, synthesize and act upon strategic information and changes within the environment.
  • Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of backgrounds and disciplines.
  • Demonstrated decision-making and problem-solving capability; ability to negotiate skillfully to achieve a fair outcome or promote a common cause.
  • Compensation :

    Targeted Base : $165,543 - 204,494

  • 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.

    [job_alerts.create_a_job]

    Associate Regulatory • Cambridge, MA, United States

    [internal_linking.related_jobs]
    Associate Director, Radiopharmaceutical Development

    Associate Director, Radiopharmaceutical Development

    Artbio • Cambridge, Massachusetts, United States, 02138
    [job_card.full_time]
    Associate Director, Radiopharmaceutical Development.As part of ARTBIOs CMC team, the Associate Director will drive the radiopharmaceutical development of Radioligand Therapy (RLT) products by desig...[show_more]
    [last_updated.last_updated_30]
    Associate Director, Regulatory Affairs – Contract

    Associate Director, Regulatory Affairs – Contract

    Nuvation Bio, Inc. • Boston, MA, United States
    [job_card.full_time]
    Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Information Technology Senior Management Forum • Boston, MA, United States
    [job_card.full_time]
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, US Omnichannel & Marketing Capabilities

    Associate Director, US Omnichannel & Marketing Capabilities

    Galderma • Boston, MA, United States
    [job_card.full_time]
    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, Regulatory Affairs (Biosimilars)

    Senior Manager, Regulatory Affairs (Biosimilars)

    Fresenius Kabi USA, LLC • North Andover, MA, United States
    [job_card.full_time]
    The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director Regulatory Labeling

    Associate Director Regulatory Labeling

    Akebia Therapeutics • Cambridge, MA, United States
    [job_card.full_time]
    Associate Director Regulatory Labeling .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...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Associate Director - ExploR&D External Partnering - Molecule Discovery and Technology Licensing

    Eli Lilly and Company • Boston, MA, United States
    [job_card.full_time]
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Regulatory Diagnostics Associate Director

    Regulatory Diagnostics Associate Director

    Novartis • Cambridge, Massachusetts, United States
    [job_card.full_time]
    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.The Regulatory ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Global Regulatory Liaison Office - Logistics, Senior Associate

    Global Regulatory Liaison Office - Logistics, Senior Associate

    State Street • Boston, Massachusetts, United States
    [job_card.full_time]
    This job is with State Street, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Who we are ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director Regulatory Strategy

    Associate Director Regulatory Strategy

    EPM Scientific • Boston, MA, United States
    [job_card.full_time]
    Associate Director of Regulatory Strategy.A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented.Associate Director of Regu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director / Director of Drug Safety / PV

    Associate Director / Director of Drug Safety / PV

    Vivid Resourcing • Boston, MA, United States
    [job_card.full_time]
    Senior Director Pharmacovigilance.Pharmacovigilance / Drug Safety.The Director of Pharmacovigilance will lead and oversee all aspects of post-marketing and clinical safety surveillance activities, ...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Regulatory Affairs Associate Director, IVD - Leader

    Regulatory Affairs Associate Director, IVD - Leader

    GRAIL • Boston, MA, United States
    [job_card.full_time]
    A pioneering healthcare company in Boston is seeking a Regulatory Affairs professional to develop and implement regulatory strategies for innovative cancer detection products.The ideal candidate wi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Regulatory Lead, Oncology

    Associate Director, Global Regulatory Lead, Oncology

    Takeda • Boston, MA, United States
    [job_card.full_time]
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Regulatory Affairs

    Associate Director, Global Regulatory Affairs

    Biontech • Cambridge, MA, US
    [job_card.full_time]
    Associate Director, Global Regulatory Affairs.Cambridge, US; New Jersey, US | full time | Job ID : 9842.BioNTech is a Nasdaq listed Germany-based global biotechnology commercial stage company with U...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Diagnostics Associate Director

    Regulatory Diagnostics Associate Director

    Novartis Group Companies • Cambridge, MA, United States
    [job_card.full_time]
    The Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including Companion Diagnostics (...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Labeling Lead

    Associate Director, Global Labeling Lead

    Boston Staffing • Boston, MA, US
    [job_card.full_time]
    Associate Director, Global Labeling Lead.At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.By focusing R&D ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Regulatory Affairs Strategy

    Director, Regulatory Affairs Strategy

    BlueRock Therapeutics • Cambridge, MA, United States
    [job_card.full_time]
    BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.T...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Pricing and Contracting

    Associate Director, Pricing and Contracting

    Intellia Therapeutics • Cambridge, MA, US
    [job_card.full_time]
    Associate Director, Pricing & Contracting.As the Associate Director, Pricing & Contracting at Intellia Therapeutics, Inc. CRISPR-based therapies to market.This is a career-defining opportunity to pa...[show_more]
    [last_updated.last_updated_30] • [promoted]