Responsibilities

Specifically, the Director, Regulatory Affairs will:

• Provide Regulatory Affairs leadership for, and day-to-day management of, the Company’s clinical programs including internal Phase 1-3 clinical programs and investigator-initiated INDs, as well as regulatory oversight of manufacturing;
• Contribute significantly to the development of regulatory strategy plans and be responsible for implementation of regulatory strategy;
• Oversee all submission activities (IND/CTA, trial maintenance, BLA) and health authority interactions (meeting requests and preparation of briefing documents), including content requirements while ensuring timelines are met;
• Write significant portions of INDs/CTAs, BLAs, responses to global authorities, etc., in coordination with clinical, pre-clinical, and CMC departments;
• Oversee the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to Company regulatory information and to provide reports to management;
• Collaborate with CMC, QA, and QC operations to ensure compliance of all activities related to FDA and ISO regulations, and quality system standards;
• Monitor the US and international regulatory environments, and provide executive management with assessments of the impact of new and changing regulations on the Company’s business, as well as develop and implement training programs with other functional groups to assure Company awareness of all requirements and maintain compliance with all current regulations;
• Review and approve Company policies and procedures for the regulatory function and work with QA/QC departments to implement needed Standard Operating Procedures.

• Advanced biologic/medical degree preferred.
• At least 10 years of progressively responsible regulatory/quality management experience in industry with specific oncology and monoclonal regulatory experience.
• Thorough knowledge of FDA and ICH regulations and requirements including GCPs, GMPs, and GLPs especially as they relate to biologic and oncologic development.
• Proven success negotiating with regulatory agencies, including working knowledge of biologic development process/requirements in the US, EU and ROW.
• Ability to organize, negotiate, and lead team in strategic discussions with regulatory agencies and to lead discussions with executive management team on strategy and policy issues.
• Candidates must be able to demonstrate strong leadership, interpersonal and communications skills (written and oral), in addition to demonstrating well-developed negotiating, project management, and problem-solving skills.