Regulatory Affairs Manager

This position is located onsite in San Diego, CA

As the Manager of Regulatory Operations, you will oversee the planning, coordination, and execution of regulatory IND submissions and maintenance activities to ensure compliance with global regulatory requirements. You will lead a team of regulatory professionals, collaborate with cross-functional departments, and manage timelines to support the development and approval of pharmaceutical and biotechnology products. Your role will involve developing and implementing regulatory strategies, maintaining up-to-date knowledge of regulatory guidelines, and ensuring the timely and accurate submission of regulatory documents. The ideal candidate will possess strong leadership skills, extensive regulatory experience, and a track record of successful submissions in the life sciences industry

Responsibilities:

• File multiple original INDs per year for new product candidates.
• Manage multiple active INDs/CTAs in Phase 1/2 trials concurrently, complete and track various types of amendments, IND Safety Reports, IND Annual Reports/DSURs, and responses to information requests from global Regulatory Agencies. Control and maintain regulatory submission logs and files in a secure and organized manner.
• Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
• Responsible for the preparation, submission, distribution and archiving of all regulatory submissions, including original INDs, amendments, safety reporting and follow-ups, annual reports and ongoing application maintenance.
• Assist in preparation of IND/CTR documents in eCTD format for original and multiple active INDs, including formatting, publishing, and organizing files in an eCTD compliant manner. Maintain templates which meet Kumquat and regulatory CTD submission standards and suggest updates as necessary.

Requirements/Skills:

• Minimum Bachelor’s degree.
• Experience working in oncology.
• Prior hands-on experience in IND submission via eCTD submission software.
• Working knowledge with US drug regulations as well as ICH and US guidance documents.
• General understanding of pre-IND to Phase 2 regulatory submissions for investigational new drugs and FDA expedited approval programs for serious conditions.