Associate Director Regulatory Labeling

Akebia Therapeutics•Cambridge, MA

5d•$165,543 - $204,494

About The Position

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.

Requirements

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
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.

Nice To Haves

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

Responsibilities

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.