Associate Director, Regulatory Affairs

The Senior Manager/Associate Director of Regulatory Affairs will assist in the development and implementation of regulatory strategies to advance Cogent’s precision kinase inhibitors in oncology and rare diseases. This individual will provide strategic input and regulatory support to cross-functional development teams. Working alongside senior Regulatory staff, this individual will be a key contributor to Cogent’s project and regulatory teams.

• Support global regulatory nonclinical and clinical strategy development and operational regulatory activities for the development, commercialization, and life cycle management of assigned project(s);
• Attend cross-functional team meetings as a key regulatory voice (e.g., protocol reviews, report reviews, development plans)
• Prepare and coordinate timely submission of global regulatory documents and responses to queries from regulatory authorities (e.g., INDs, CTAs, NDAs, MAAs)
• Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.;-
• Acting as interface with Health Authorities;
• Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions for assigned programs
• Support and organize preparations for Health Authority meetings;
• Research, analyze, interpret, and disseminate information related to regulatory or scientific topics (i.e., from external meetings, workshops, guidance documents, conferences)
• Contribute to the development of internal regulatory policies, processes, and procedures.

• At least 4 years of experience in Regulatory Affairs 
• Regulatory filing experience (e.g, INDs, CTAs, NDAs, MAAs or equivalent); 
• Experience in rare disease and oncology; 
• Solid working knowledge of drug development processes and US regulatory requirements required; knowledge of EU, UK, Canada, ROW regulatory requirements is preferred. 
• Strong project management skills, with a track record of delivering high impact results; 
• Outstanding and versatile written and oral communication skills; 
• Bachelor’s degree required. Advanced degree in a Life Science or related discipline preferred.