Reporting to the Chief Medical Officer, the Senior Director/Vice President, Regulatory Affairs
will serve as the global regulatory leader for defining and implementing the regulatory strategy across Apollomics product pipeline. He/she is responsible for the regulatory filing strategy for US FDA and all global interactions and filings, annual reports, as well as responses to requests from these agencies. In effect, this individual will provide regulatory leadership to cross functional teams ensuring effective communication with business partners and health authorities world-wide.
Primary Duties and Responsibilities
- Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets.
- Establish and develop regulatory policies, procedures and best practices commensurate with the requirements of a rapidly growing company.
- Serve as liaison (single point of contact) with FDA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements, ensuring registration strategies adhere to corporate objectives.
- Contribute and lead the management, planning, coordination, and preparation of all documents submitted to FDA and other Health Authorities in support of INDs, BLAs, NDAs, amendments, safety reports, and annual updates.
- Ensure completeness and accuracy of information provided in regulatory submissions.
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
- Oversee preparation of regulatory presentations for clinical project team meetings and communicating project status and issues to executive management. Serve as the regulatory representative at project meetings and interacting with cross functional team to achieve corporate and study goals.
- Develop and oversee the annual budget for the Department of Regulatory Affairs.
- Advanced degree is preferred (MS/PhD/PharmD/MD)
- 15+ years industry experience in regulatory affairs in bio/pharma industry with multiple regulatory disciplines (preclinical, clinical, CMC, labeling, etc.).
- Strong knowledge of FDA regulations and EU CTA requirements; direct oncology regulatory affairs with FDA and major health authorities preferred.
- Delivery of a number of major applications (NDA/BLA, etc.) and lead role preferred.
- Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities.
- Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, PSURs, briefing packages and other regulatory submissions required.
- Experience interacting/negotiating with regulatory authorities (e.g. FDA, EMA, etc.).
- Working knowledge of electronic publishing/file management systems.
- Strong leadership and communication skills and experience in working with multiple functional areas.
- Prior experience in oncology, immunology, and targeted therapies would be a plus.
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
- Ability to motivate and lead others.
- Team player, ability to thrive in a collaborative and fast-paced environment and work well within cross-functional teams, maintain positive relationships with management, peers, subordinates and external partners.
- Excellent oral and written communication skills.
- Highly detailed oriented, well organized with the ability to prioritize multiple tasks to meet corporate deliverables.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.