Regulatory Affairs Manager

2 weeks ago

San Diego, California, United States Kumquat Biosciences Inc Full time
Position Overview

The individual will be accountable for overseeing the Regulatory Operations at Kumquat Biosciences Inc., ensuring the timely filing of numerous original Investigational New Drug (IND) applications annually and managing a portfolio of active INDs in Phase 1/2 clinical trials across various regions including the US, Canada, EU, and APAC.

Key Responsibilities:

  • Lead the submission of multiple original INDs for new product candidates developed by Kumquat.
  • Oversee the management of concurrent active INDs/Clinical Trial Applications (CTAs) in Phase 1/2 trials, ensuring the completion and tracking of amendments, IND Safety Reports, and Annual Reports.
  • Maintain comprehensive regulatory submission logs and files in a secure and organized manner.
  • Collaborate with project teams to ensure all regulatory submissions are accurate and submitted on schedule, aligning with corporate objectives.
  • Prepare, submit, and archive all regulatory documents, including original INDs, amendments, and safety reports.
  • Assist in the preparation of IND/CTR documents in eCTD format, ensuring compliance with Kumquat and regulatory standards.
  • Engage with regulatory agencies to facilitate communication and compliance.
  • Support Quality Assurance, pre-Clinical and Clinical teams, and other stakeholders in the management of active INDs and adherence to Kumquat policies.
  • Stay informed about evolving regulatory standards in the US and other ICH regions.
  • Conduct regulatory research to inform strategic decisions regarding Kumquat products.
  • Contribute to the development and implementation of departmental policies aimed at continuous improvement.

Qualifications:

  • Bachelor's degree; advanced education is advantageous.
  • Experience in oncology is preferred.
  • Hands-on experience with IND submissions using eCTD submission software is essential.
  • Familiarity with US drug regulations and ICH guidance documents is required.
  • Understanding of regulatory submissions from pre-IND to Phase 2 for investigational new drugs.
  • Proven ability to manage multiple projects and submissions simultaneously.
  • Strong communication skills, both written and verbal, along with technical writing and editing capabilities.
  • Exceptional organizational skills and attention to detail.
  • Demonstrated leadership and interpersonal skills, with the ability to work effectively in a team environment.

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