Regulatory Affairs Specialist/レギュラトリアフェアーズスペシャリスト
給与 ¥8000000 - ¥15000000 per annum
担当コンサルタント Khaliunaa Chuluunkhuu
A global pharmaceutical company is in search of an individual with a degree in pharmacy, biology, or chemistry plus several years’ experience in R&D to join its team as Regulatory Affairs Specialist. This is a highly multifaceted role suitable for an experienced professional who will evaluate candidate products, interface with regulatory authorities, and work closely with global RA.
- Evaluate candidate products for in-license, expansion of indication, new formulation, etc. and advise on effective developments
- Create strategy for consultations related to new products or additional indications with regulatory authorities, global RA, and the pharmaceutical industry
- Monitor marketing activities and ensure they are in compliance with relevant laws
- Serve as a mentor to other departmental activities from a regulatory perspective
- Perform regulatory review of and input for promotional materials
- A bachelor’s degree in pharmacy, biology, chemistry, or a related subject; a master’s or doctorate degree preferred
- 5+ years’ experience in R&D or in a regulatory area at a pharmaceutical company
- Prior experience (3 years) with J-NDA including s-NDA for additional indications
- Strong communication skills; ability to communicate in English (reading, writing, and speaking) with non-Japanese individuals required, even if not fluent in English
About the Company:
A global specialty pharmaceutical company with an outstanding international reputation and lasting presence in the industry that develops, produces, and distributes a broad range of products to retail and wholesale customers. If you are ready to drive your career forward in an international environment, this may be the ideal opportunity for you.
メディカル, 医療, ヘルスケア, 薬学, 薬事