Senior Regulatory Operations Associate

Syndax Pharmaceuticals is looking for a Senior Regulatory Operations Associate

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 Senior Regulatory  Operations Associate, you will play a critical role in ensuring that Syndax's innovative cancer therapies comply with all regulatory requirements. You will be responsible for assisting in the formatting and publishing of regulatory documents, managing regulatory submission timelines, and collaborating with cross-functional teams to support the development and commercialization of our products.

Key Responsibilities: 

• Assist in eCTD preparation, publishing, eCTD validation and electronic submission of regulatory documents to health authorities, including INDs, NDAs, BLAs, and MAAs.
• Veeva RIM business user: archive correspondence, build submission outlines, manage dashboards, coach/train end users.
• 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.
• Help review, improve and develop work instructions and SOPs.
• Monitor and interpret regulatory requirements and guidelines to ensure compliance.
• Provide regulatory support during clinical trials, including CTA/CTRs via CTIS; SPL and other portals such as CDER Direct.
• Maintain regulatory electronic files and documentation in Veeva RIM in accordance with company policies and procedures.

Desired Experience/Education and Personal Attributes: 

• Bachelor's degree preferred.
• 3-5 years of experience in regulatory operations within the biopharmaceutical industry.
• Experience with eCTD and electronic regulatory submissions.
• Strong knowledge of FDA, EMA, and other global regulatory requirements, especially for electronic submissions.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational skills.
• Ability to work independently, remote and as part of a team.
• Proactive and able to manage multiple projects simultaneously.

Location: Syndax’s corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $95,000 - $115,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 (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.

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