Senior RA Specialist/シニアRAスペシャリスト
給与 ¥6000000 - ¥8000000 per annum
担当コンサルタント Khaliunaa Chuluunkhuu
A global pharmaceutical company is recruiting for the position of Senior RA Specialist. The candidate selected for this role will be educated to bachelor degree level and possess at least 5 years’ experience in R&D or regulatory affairs at a pharmaceutical company. This dynamic role will see you working closely with global RA and interfacing with regulatory authorities.
- Evaluate candidate products for in-license, expansion of indication, new formulation, etc., and advise on effective development
- Create strategy for consultations in relation to new products or additional indications with regulatory authorities (MHLW, PMDA, etc.) and prepare application documents for J-NDAs/s-NDAs
- Interface with regulatory authorities, global RA, and the pharmaceutical industry
- Monitor marketing activities and ensure they comply with relevant laws
- A BA in pharmacy, biology, chemistry, or related field; MA or doctorate preferred
- 5 years’ experience in R&D or regulatory area at a pharmaceutical company
- Prior experience/familiarity with J-NDA including s-NDA for additional indications, at least 3 years
- Ability to communicate with non-Japanese speakers in English, including reading and writing; speaking required even if not fluent
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.
薬事, メディカル, 医療, ヘルスケア, R&D, 製薬業界