Associate Director Regulatory Labeling

Role Summary

Associate Director Regulatory 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

• 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.

Education