Associate Director, Regulatory Affairs

Syndax Pharmaceuticals is looking for an Associate Director, 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 clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

Syndax has an exciting new opportunity for an Associate Director, Regulatory Affairs. This position will operate mostly remote and occasional travel will be expected.

Key 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.

Desired Experience/Education and Personal Attributes:

• 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.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

About Syndax:
Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

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