This biotech startup is developing intratumoral immunotherapies to fight cancer in a new way. They are seeking a Chief Regulatory Officer who can oversee all aspects of Regulatory Affairs for their development programs and serve as a member of the company’s Executive Leadership Team. Reporting to the CMO, you will provide oversight and leadership for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. This company offers innovative science, a patient-focused culture, and the ability to work remotely (with some regular visits to their office.) With two INDs planned for 2023, this an exciting time to join this growing organization!
Responsibilities:
- Lead and manage the global regulatory affairs function to ensure adherence to appropriate regulations and standards
- Provide expertise and serve as internal subject matter expert on global regulatory guidelines, current regulatory landscape, and regulatory precedent for immuno-oncology indications
- Implement and oversee global regulatory strategy and activities for existing pipeline and clinical assets
- Serve as primary liaison with FDA and other regulatory authorities
- Determine global regulatory requirements and prepare regulatory submissions for all new/modified drugs, medical devices, and Combination (drug/device) Products. This includes but not be limited to IND’s, BLA’s, NDA’s, 510 (k)’s, IDE’s, PMA’s, and their foreign equivalents
- Develop standard operating procedures for global regulatory affairs and maintain internal and external documents
- Collaborate with Clinical, Medical, CMC, Quality Assurance, Pharmacovigilance, Bioanalytics, Device Development and Commercial groups to develop global regulatory strategy at all stages of drug, device and Combination (drug/device) Product development
- Develop and maintain regulatory affairs department budget
- Serve as a senior member of the company’s Executive Leadership Team
- Interact with FDA, EMEA and other Regulatory Agencies on all matters related to drug, device, and Combination (drug/device) Product filings and commercial products
- Provide guidance on regulatory approaches to optimize new product development
- Manage the development, coordination, preparation, and timely submission of all regulatory documents
- Ensure project teams prepare high quality international and domestic filings/registrations and responses to agency requests within established timelines
- Oversee the review and/or management of all regulatory reporting activities
- Review submission packages, labeling revisions, or promotional materials for compliance with global regulations
- Provide regulatory leadership for due diligence activities, partnering activities and product/company integrations
- Hire, build and lead a team of Regulatory professionals
Qualifications:
- Advanced degree such as PharmD, MD, or PhD preferred
- Minimum of 10 years of Regulatory Affairs experience for oncology immunotherapy products
- Immuno-oncology experience specifically in checkpoint blockade monoclonal antibodies highly desired
- Must have strong experience working with FDA’s Oncology Center for Excellence and/or Office of Oncologic Diseases. Experience working at FDA’s OCE or OOD a big plus.
- Regulatory experience with developmental stage Combination (drug/device) Products a plus but not required
- Some Regulatory CMC experience (or Reg CMC oversight) for mAbs a plus
- Ability to speak Mandarin a plus, but not required
- Must have experience managing Regulatory staff
- Strong verbal/written communication and technical presentation skills
- Ability to manage team of professionals with diverse regulatory expertise in oncology immunotherapeutics, Class III Medical Devices, and Combination (drug/device) Products
- Ability to interface with Alliance Partner Regulatory and other Teams
- Exceptional leadership, project management, communication and presentation skills
- Ability to manage diverse department and develop personnel in accordance with company objectives
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment