Job Details
Job Description
Manager shared feedback that recent resumes had the wrong experience (CMC or device, which is more technical than strategic) or are completely operational. Requires candidates that have worked on medicinal products (small molecule or biologic) marketing applications like NDA, BLA, MAA.
This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development.
Additionally, 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.
Education and Experience:
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.
At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development.