Regulatory Affairs - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
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.
- 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.
- MUST HAVE extensive experience in field marketing applications (NDA, BLA, MAA).
- 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 (regional and/or global), in early development.
Source : Katalyst Healthcares & Life Sciences