Regulatory Affairs

Summary

Join Syndax Pharmaceuticals as a Contractor, Regulatory Affairs and play a critical role in ensuring compliance with regulatory requirements for innovative cancer therapies. You will assist in preparing regulatory documents, manage timelines, and collaborate with cross-functional teams. Key responsibilities include coordinating regulatory submissions, providing regulatory support to clinical trial teams, maintaining regulatory knowledge, monitoring regulatory intelligence, and managing timelines. The ideal candidate will possess a BA/BS in Life Science/Health or equivalent, minimum 3 years of relevant experience, and knowledge of global regulatory regulations and guidelines. Hematology/oncology experience and CDX experience are preferred. The position is open to candidates from any location, with a preference for east coast locations.

Requirements

• A BA/BS in Life Science/Health related degree or equivalent
• Minimum 3 years of Regulatory affairs or related industry experience
• Knowledge and understanding of global regulatory regulations and guidelines
• 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

• Work with Regulatory Affairs leadership to develop and document processes, procedures and SOPs
• Coordinate and prepare regulatory submissions to support clinical trials, including original IND/CTA submissions, new protocols, protocol amendments, CSRs, safety reports, new investigator information, and annual reporting (e.g., IND, DSUR, orphan, NDA/BLA, PADER, PBRER, etc.)
• Provide regulatory support to clinical trial teams (e.g., review clinical protocols, informed consent forms, Investigator’s Brochures, and site documentation)
• Provide clinical study updates to Regulatory Affairs leadership, seeking input from regulatory colleagues as needed
• 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
• Manage regulatory timelines and ensure timely submissions
• Collaborate with cross-functional teams, including clinical, manufacturing, and quality assurance, to gather necessary information for regulatory submissions
• Maintain regulatory files and documentation in accordance with company policies and procedures

Preferred Qualifications

• Hematology and/or oncology
• CDX experience