Associate Director, Regulatory Operations

fully remote

Main responsibilities:

1. Manage the preparation of eCTD submission-ready documents and ensure quality, accuracy, and adherence to regulatory guidelines.
2. Prepare and submit INDs, CTAs, annual reports, DSURs, and safety reports to regulatory authorities.
3. Track and report submission activities, manage processes for archiving health authority correspondence and submissions, and ensure compliance with regulatory standards.
4. Support the regulatory team across all aspects of Regulatory Affairs related to the development of novel therapeutics, including nonclinical, clinical, and quality.
5. Plan and monitor regulatory activities, draft SOPs and work instructions, and identify best practices and regulatory precedents.
6. Collaborate with internal preclinical, clinical, CMC, and safety teams, to produce high-quality regulatory submission documents and ensure completion of IND submissions and amendments.

Essential Experience:

• Biologics development and oncology expertise.
• 7+ years of experience in regulatory operations.
• Extensive global regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with Health Authorities and working with project teams.
• Experience implementing and maintaining document management systems.

Essential Qualifications:

• Attention to detail and accuracy in document preparation and submission.
• Ability to be both strategic and operational, including hands-on and higher levels.
• Exceptional organizational skills, effective verbal and written communication and interpersonal skills, and a team approach.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Self-motivated and able to work independently.

Additional points:

-- This is a fully remote role with quarterly travel to headquarters.

-- Competitive compensation package includes base salary + bonus + options.