Immunomic Therapeutics, Inc. (ITI) an HLB Company, is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE® platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in several cancers. The company has built a pipeline leveraging UNITE® with programs in oncology, animal health, infectious disease, and allergy.

We are seeking a Manager of Regulatory Affairs to join our ITI team. The ideal candidate will have experience in development of regulatory documents for filing with the FDA (e.g., Meeting documents, INDs submissions, Annual Reports, etc.). The candidate will provide regulatory support for ITI’s development projects and regulatory documents for filing with the FDA. The candidate will also collaborate with ITI teams to deliver commitments to the organization and to patients.

• Assists in the development of regulatory strategies and their execution.
• Coordinates the preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol amendments and agency correspondence, etc.
• Identifies regulatory risks and proposes mitigations to support project team and regulatory affairs goals.
• Oversees the archiving and maintenance of Regulatory documents and chronologies within the document management system.
• Ensures conformance to 21 CFR regulations.
• Performs Regulatory Agency product approval intelligence and tracking systems.
• Contributes to process improvement.
• Supports other Regulatory activities as needed.

• Must interface face-to-face with all levels within the organization and outside vendors.

• B.S. Degree in Science or related field with 3 plus years of regulatory experience, Master’s a plus
• Demonstrated experience with preparing Pre-IND, IND and related non-US submissions with therapeutic biologics preferred
• Excellent written and verbal communication skills
• Solid understanding of the drug development process
• IT capability and competence with eCTD publishing systems preferred

• Extended sitting and working at a computer for long periods of time.

• Hybrid, 3 days at the office/week

• Efficient in Microsoft Word, Excel, Project, and Outlook

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2024 RA 003 in the subject line.

Equal Opportunity Employer