Manager, Regulatory Affairs Operations

Syndax Pharmaceuticals is looking for a Manager, Regulatory Affairs Operations

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 Pharmaceuticals is searching for a Manager, Regulatory Affairs with a focus on operations to support quality, timely regulatory submissions for all company products. This person will implement regulatory systems, establish processes, and oversee global submissions. They will work closely with Regulatory Leads to plan and schedule project timelines and track deliverables.

Key Responsibilities:

• 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).
• Coordinate and prepare responses to requests for information from health authorities.
• Manage the regulatory operations function, to include management of publishing vendors.
• Coordinate with Regulatory Medical Writing, IT, and other functional areas as needed to accomplish Regulatory Operations objectives.
• Serve as representative to Regulatory Agencies on technical aspects of eCTD/NeeS filings.
• Manage customization of INDs/IMPDs, BLAs/MAAs, SPL, and briefing dossiers, provide document formatting support, and organize submissions in a professional, compliant, high-quality, and timely manner.
• Maintain expert knowledge of regional regulatory publishing requirements and precedents that may affect company filings.
• Manage the implementation of systems and process improvements to support greater efficiency in regulatory operations.
• Maintain a world-class regulatory operation system and standards including publishing and archiving.
• Interface regularly with Regulatory Leads to maintain an overview of upcoming submissions for all products and prioritize between the different projects.
  
  

Desired Experience/Education and Personal Attributes:

• BA/BS in Life Science/Health related degree or equivalent.
• Minimum of 3 years of Regulatory Affairs/Operations experience in the biotechnology/pharmaceutical industry.
• Knowledge and understanding of global regulatory regulations and guidelines.
• 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.
• Hands-on contributor willing to perform a wide variety of tasks to support business needs.
• 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.

About Syndax:

Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Companys 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.

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.