Associate Director Regulatory Labeling

Role Summary

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

• 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.

Qualifications

• Required: BA/BS Degree
• Required: 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: Advanced degree (MS, PhD, PharmD, or JD)
• Preferred: Experience with launching new products and/or new indications

Skills

• 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 leadership and collaboration across diverse teams
• Forward thinker with industry knowledge and ability to synthesize and act upon strategic information
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus
• Demonstrated decision-making and problem-solving capability; able to negotiate to achieve outcomes

Education

• Required: BA/BS Degree
• Preferred: Advanced degree (MS, PhD, PharmD, or JD)