Senior Regulatory Operations Associate

Summary

Join Syndax Pharmaceuticals as a Senior Regulatory Operations Associate and play a critical role in ensuring compliance with regulatory requirements for innovative cancer therapies. You will assist in preparing and publishing regulatory documents, manage submission timelines, and collaborate with cross-functional teams. Key responsibilities include eCTD preparation and submission, Veeva RIM system usage, timeline management, cross-functional collaboration, SOP development, regulatory guideline interpretation, and clinical trial support. The ideal candidate possesses a Bachelor's degree (preferred), 3-5 years of relevant experience, eCTD expertise, strong knowledge of global regulatory requirements, and excellent communication and organizational skills. Syndax offers a competitive compensation and rewards package, including base pay, equity, bonuses, and benefits.

Requirements

• 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

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

Preferred Qualifications

Bachelor's degree preferred

Benefits

• 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