Global Pharmaceutical Company
Regulatory Affairs Manager/Expert
- Represent Development RA group in the responsible Project Team
- Develop submission plan in collaboration with RPM and manage/coordinate preparation of all regulatory documentation, i.e. briefing document for PMDA consultation, CTN documents, JNDA documents (CTD), etc.
- Develop regulatory strategy for each project
- Create HA interaction plan
- Represent the Company in any interactions with HAs
- Review and provide regulatory input to all regulatory documentation
- Collect and analyze updated regulatory-related information and share with the relevant people
- 5 or more years of experience of regulatory affairs in pharmaceutical industry
- Proven expertise in development and management of regulatory strategy for Japan
- Demonstrated experience in interaction with HAs in Japan
- Experience of regulatory affairs in in vitro diagnostics/companion diagnostics development (preferable)
- Business level English
- Proven leadership and management skills in the functional and cross-functional team
- Good interpersonal communication skill
- Negotiation skill
- Business-orienting thinking
(Experiences and skills will be considered)
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Further details about the company and position will be notified at a later date.