Description
Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA with the following requirements : Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or life sciences or related field or foreign academic equivalent plus 8 years related experience.
- Prior experience must include : Strategize, author, and review Global and European Risk Management Plans (RMP) Core-RMP, EU-RMP other RMP including those for first or supplementary marketing authorizations applications (NDA submissions);
- Advise product team on the maintenance and implementation of REMS program for assigned product and support FDA response requests;
- Support health authority inspections and audits (on behalf of the company) for assigned products including supporting FDA Inspections and MHRA (The Medicines and Healthcare products Regulatory Agency) inspections;
Engage in cross-functional strategic discussions for management of activities including planning, authoring and review of periodic aggregate reports like Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER / PAER) in compliance with global regulations.
Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US.
Full time. $195,200 - $283,200 per year.
Apply on-line at and search for Req #R0123103.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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