Syndax is looking for a Contractor, Regulatory Affairs

 

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

 

The Role: 

As a Contractor, Regulatory Affairs, you will play a critical role in ensuring that Syndax's innovative cancer therapies comply with all regulatory requirements. You will be responsible for gathering and synthesizing regulatory and competitive intelligence and regulatory research and collaborating with cross-functional teams to support the development and commercialization of our products.

Responsibilities:

Monitor and gather regulatory intelligence and updates to both the competitive environment and Health Authority guidance, initiatives and regulatory practices that may impact internal regulatory strategy, and summarize for team assessment Conduct and summarize regulatory research for actionable team use Assess and apply regulatory knowledge/information to advance our development programs Ad hoc project support for Regulatory Affairs projects Develop and maintain knowledge of US, EU and ROW regulations to assure programs and internal processes are in compliance with applicable regulations Working with Regulatory Affairs leadership to develop and document processes, procedures, and SOPs Prefer experience in companion diagnostics (CDx) / precision medicine to advise project teams on regulatory strategies and manage related submissions

Senior Manager Requirements:

A BA/BS in Life Science/Health related degree or equivalent Minimum 5 years of Regulatory affairs or related industry experience Knowledge and understanding of global regulatory regulations and guidelines Knowledge and understanding of drug development from early phase through post-marketing CDx/Precision Medicine experience preferred Hematology and/or oncology preferred 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

 

Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.  

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.