The Director, Regulatory Affairs provides regulatory leadership in support of the development programs at Seattle Genetics. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the regulatory affairs department. The successful candidate will serve as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management.
• Develop and implement regulatory strategy
• Represent the regulatory function on cross-functional development teams
• Provide regulatory guidance and strategy including identifying and assessing regulatory risks
• Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, and MAA)
• Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
• Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
• Coordinate and prepare responses to requests for information from regulatory authorities
• Train and mentor other regulatory affairs personnel
• MD, PhD or PharmD in a scientific discipline preferred along with at least 8 years of experience in Regulatory Affairs
• BS/MS requires at least 10 years of relevant experience in Regulatory Affairs
• Oncology experience required
• Knowledge and understanding of global regulations and guidelines
• Previous experience in the preparation and submission of regulatory documents
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.).
• Experience with investigational drugs, including late stage development, and marketed products
• Previous experience with companion diagnostic development highly desirable
• Ability to work in a cross-functional team environment
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable.
• Strong attention to detail and the ability to handle multiple tasks
• Excellent organizational, computer and documentation skills and an ability to prioritize effectively
• Strong interpersonal skills including verbal and written communication
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.