Director Regulatory Affairs
The Director, Regulatory Affairs CMC provides regulatory leadership in support of commercial and development programs at Seagen. 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 CMC group within the regulatory 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 CMC 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
- Supervise other regulatory affairs CMC personnel
- MD, PhD or PharmD in a scientific discipline preferred along with at least 8 years of experience in Regulatory Affairs CMC
- BS/MS requires at least 10 years of relevant experience in Regulatory Affairs CMC
- 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, Type C meetings and/or EU oral explanations/scientific advice, etc.).
- Experience with small molecule and biologic commercial and investigational drugs, including late stage development
- Previous experience with combination products is highly desirable
- Ability to work in a cross-functional team environment
- Prior managerial experience, with direct supervision of early- to mid-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
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.