Working under the direction of the Vice President, the Regulatory Affairs Director will be responsible for the oversight of all regulatory activities associated with clinical trials for the non-profit organization and its affiliated entities.
Understands all the requirements and mechanics related to the Investigational New Drug Application process
Interacts regularly with officials and representatives from the FDA and NCI on behalf of the organization
Maintains clinical trial regulatory submissions and assists with the submission and acceptance of these submissions
Assesses clinical trial drug packages in pharmaceutical and clinical settings
Leads preparation, review and approval of clinical trial regulatory documents
Assists in ensuring regulatory compliance with clinical trial agreements and related documents
Provides clinical trial regulatory input on an as-needed basis
Provides clinical trial regulatory viewpoints and expertise to organization teams
Reviews clinical trial protocols and clinical trial plans and ensures alignment with regulatory requirements
Ensures clinical trial quality management, sourcing and supply regulatory adherence is achieved and maintained in all related clinical trial processes
Supports line managers with creating, implementing and developing clinical trial regulatory strategies
Proposes process improvements for the organization and assists and follows through in implementation
Reviews and creates standard operating procedures for the organization
Performs regulatory trainings for management and staff
Responsible for ad hoc projects as determined by the Vice President
The Regulatory Affairs Director role requires exemplary interpersonal, communication and education skills. This role necessitates self-direction, motivation, organization, strict attention to detail and problem-solving abilities.
The Regulatory Affairs Director must have a comprehensive understanding of government and regulatory agencies that oversee clinical trials, an in-depth knowledge of the laws, regulations and guidelines that govern the registration and conduct of clinical trials, and experience with the clinical trial regulatory review processes in the United States, Canada and Europe. The Regulatory Affairs Director should also be well versed in clinical trial regulatory strategy development, use and interpretation of clinical trial regulations and guidelines and interactions with government agencies that regulate clinical trials.
Minimum of five (5) years relevant pharmaceutical experience is required
Experience and knowledge of both pharmaceutical industry and clinical trial research environments is required
Experience or familiarity with National Cancer Institute (NCI) funded clinical trials and/or U.S. Food and Drug Administration (FDA) Investigational New Drug Applications is strongly preferred
Master’s degree in a related discipline from an accredited college or university is required. Pharm D. is preferred.
Internal Number: DirRegAffairs
About Coalition of Cancer Cooperative Groups
The Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.
The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.