※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials (with the advice of Director or Associate Director as needed). Also review the process of promotional materials from Regulatory point of view. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical tasks required for product development and life cycle management in a timely and appropriate manner. Since labeling is a driver of all NDA documents, the role of this position should be specialist and experienced of JPI works.
- Creating Japanese Package Inserts of new drugs and manage revisions of JPIs of post approval products to be in line with CCDS.
- Lead labeling committee in Japan for the JPI production schedule with involving other related divisions .
- Review educational materials based on the Japanese Regulations and internal SOPs.
- Review promotional materials aligning with Global Advertising & Promotion Compliance team.
- Serving as a contact person for the company, coordinates for pharmaceutical affairs matters on each product 's JPI between internal concerned departments and regulatory authority.
- Negotiate with subcontractors and external parties about pharmaceutical affairs issues as needed.
- Assist Directors when it is necessary.
- Coordinate with Global Labelling Team
- Lead Global translation project for checking accuracy of translation of JPIs.
- More than 3 years' experiences of JPI in Regulatory Affairs.
※Experiences and skills will be considered
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