You are here
Pharma Regulatory Affairs, Specialist, 10M
- Flexible working hours and Tokyo location
- Majority of trials are global trials
About Our Client
A leading US CRO is looking for a RA Senior Specialist to join their team and play a major role in the Regulatory engagements from a wide-range of clients. This company has been flexible in adapting to the Japan environment, and also implementing strengths from the US HQ. Located in Tokyo.
May oversee preparation and review of marketing regulatory applications e.g. MAA, BLA, NDA.
May oversee preparation and review of variation applications and renewals and Scientific Advice briefing documents.
May oversee authoring or review of technical information (CMC, Pre-clinical, and Clinical e.g. Regulatory Affairs Professionals with a Medical Writing background per regulations/guidelines to support regulatory applications).
May interact with the assigned Project Manager (PM) to ensure accurate financial management for general project support
The Successful Applicant
A degree or equivalent in an appropriate discipline, for example Life Sciences, Pharmacy, Chemistry, Medicine, Project Management and Design
Regulatory affairs or Pharmaceutical Industry experience
May have experience with CMC small molecule and or biologics, or Clinical or Non-Clinical background
May have experience of mentoring and peer review of documents
What's on Offer