Associate Director, Regulatory Affairs and Operations
Associate Director, Regulatory Operations
fully remote
Main responsibilities:
- Manage the preparation of eCTD submission-ready documents and ensure quality, accuracy, and adherence to regulatory guidelines.
- Prepare and submit INDs, CTAs, annual reports, DSURs, and safety reports to regulatory authorities.
- Track and report submission activities, manage processes for archiving health authority correspondence and submissions, and ensure compliance with regulatory standards.
- Support the regulatory team across all aspects of Regulatory Affairs related to the development of novel therapeutics, including nonclinical, clinical, and quality.
- Plan and monitor regulatory activities, draft SOPs and work instructions, and identify best practices and regulatory precedents.
- 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.