Syndax Pharmaceuticals is hiring a
Associate Director

Summary

Join Syndax Pharmaceuticals as an Associate Director, Regulatory Affairs and operate mostly remote with occasional travel expected. This position will direct global regulatory affairs strategies and execute regulatory activities for Syndax.

Requirements

• BA/BS in Life Science/Health related degree or equivalent; MSc, PhD or PharmD preferred
• 7+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; Global experience desired
• Previous experience managing regulatory affairs functional areas and external CROs and consultants desirable
• Substantial knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA
• Knowledge and understanding of global regulatory regulations and guidelines
• Strong working knowledge and Previous experience in the preparation and submission of regulatory documents for IND/IMPD/NDA/MAAs. Experience with investigational products; hematology and oncology experience a plus
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Strong attention to detail and the ability to handle multiple tasks
• Excellent organizational, computer and documentation skills
• Strong interpersonal skills and the ability to deal effectively with various team members. including medical, scientific and manufacturing staff

Responsibilities

• Independently directs as well as prepares global regulatory affairs strategies and executes regulatory activities for Syndax, with general guidance from manager and regulatory affairs leadership
• Fosters collaborative, efficient, and effective working relations with FDA (and other Health Authorities if necessary) to further build the cordial working relationship between Syndax and global health authorities
• Assesses the impact on new regulations, guidance or enforcements and advises the project teams on requirements to maintain compliance with regulatory activities with emphasis on research and development activities
• Coordinate and prepare regulatory submissions to health authorities including FDA, EMA and other national authorities to support clinical trials, including original IND/CTA submissions, new protocols, protocol amendments, safety reports, new investigator information, and annual reports
• Provide regulatory support to the clinical study teams (review clinical protocols, informed consent forms, Investigator’s Brochures, and site documentation)
• Drive deliverables for marketing applications
• Develop and maintain regulatory knowledge of US, EU and ROW regulations to assure programs in internal processes are in compliance with applicable regulations
• Monitor regulatory intelligence and competitive environment that may impact current internal regulatory strategy
• Coordinate and prepare responses to requests for information from health authorities