Director/Senior Director, Regulatory Affairs
Department: Regulatory Affairs
Job Title: Director/Senior Director, Regulatory Affairs
Reports To: Vice President, Business Development, Legal and Regulatory Affairs
Description:
This position is responsible for carrying out Avid’s regulatory affairs plans and programs in support of medical imaging drug development as well as corporate compliance with regulations applicable to company operations (e.g. USFDA, USDA, NRC). The individual works closely with other R&D management of the company to implement regulatory strategy, establish project and program plans and generate precise timelines, and manage and monitor the completion of all regulatory activities associated with new drug development programs.
The individual reports to the VP, Business Development, Legal and Regulatory Affairs, and receives substantial direction from senior management for Research, Product Development, and, Clinical Development regarding the preparation and filing of regulatory submissions, as well as project goal setting, timeline development and monitoring. The responsibilities of the individual in this position include:
• In close cooperation with R&D management team members, he/she establishes and implements regulatory goals for all development programs of the company.
• Is responsible for preparation and filing of INDs, IND amendments, CTAs and other regulatory submissions, and works closely with functional leaders of the company to produce high quality submissions.
• Anticipates and identifies regulatory and project development risks and makes recommendations to senior management regarding alternatives for risk mitigation.
• Works closely with chemical development, clinical development and quality functions in assuring that necessary Standard Operating Procedures are in place for the critical drug development activities of the company and our external CRO or CMO partners.
• Leads the commercial/marketing regulatory activities for the company, such as: managing pharmacovigilance of marketed products, conducting reviews of product marketing materials (e.g. advertising, medical education programs), planning and managing the filings of post-approval regulatory submissions, advising marketing and sales management regarding product education and promotion activities.
• May manage one or more persons within the Regulatory Department.
Requirements:
• An advanced degree in a scientific discipline relevant to drug discovery and development
• At least 7 years of regulatory affairs experience in a corporate drug development organization
• A high level of familiarity and understanding of FDA and ICH regulations and guidelines
• Several years experience in medical imaging drug development and direct experience working with medical imaging division of FDA is preferred
• Good working knowledge of applicable regulations, such as GLP, GMP, GCP and DDMAC regulations
Email resume to kruzik@avidrp.com