Regulatory Affairs

Responsibilities and Requirements: This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies. Be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. dditionally, this role leads the development of a global HA (Health Authority) interaction plan and strategy in collaboration with GRT (Global Regulatory Team) and is accountable for the communication of the key outcomes to senior management. MUST HAVE extensive experience in field marketing applications (NDA, BLA, MAA). dvanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred. t least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regional and/or global), in early development.