Director, Global Regulatory Affairs Strategy – Oncology
Precision Life Sciences
- Boston, MA
We are seeking a Director, Global Regulatory Affairs Strategy – Oncology for our client in the Life Sciences / Biotechnology industry.
- The Global Regulatory Affairs Lead (GRTL) for oncology will be responsible for leading the Global Regulatory Team (GRT) in the development of innovative and creative global regulatory strategies for pipeline and lifecycle assets in the company's growing and diversified oncology portfolio.
- The person will serve as the company's liaison to internal business partners including but not limited to the Global Project Team and represent regulatory at corporate governance meetings for assigned projects.
- In this role, the person will be accountable to lead the GRT and collaboratively develop and maintain the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects.
- The role works with and participates in multi-disciplinary matrixed project teams to effectively meet project deliverables while adhering to regulatory requirements for programs and products.
- The role participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations.
- The role may be assigned direct reports.
- BS/BA degree in a relevant scientific discipline is required. An advanced degree is preferred (MS/MA/PharmD/Ph.D).
- At least 6 years of relevant experience in regulatory affairs (region and/or global) including 8 years of relevant pharmaceutical/biotechnology industry experience.
- Demonstrated strategic thinker with an ability to make complex decisions and willingness to defend difficult positions
- Demonstrated leadership experience with the preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents, and negotiating with a national/regional health authority
- Demonstrated understanding of clinical development of drugs and/or innovative biologics products
- Effective communication skills, specifically excellent oral and written presentation skills
- Excellent time-management and operational skills including planning, organizing, and experience to effectively motivate and lead others
- Experience working in electronic document management systems, e.g., Veeva vault
- Organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
- Experience mentoring/coaching junior staff
- Understanding of the global oncology pharmaceutical marketplace, oncology drug development, and/or regenerative medicines
- Strong sensitivity for a multicultural/multinational environment
Wednesday, July 20, 2022