Position Summary
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.
Principal Responsibilities
- Create Japanese Package Inserts (JPIs) of new drugs and manage revisions of JPIs of post approval products to be in line with CCDS.
- Create and revise Patients Guides in line with Japanese PIs.
- Review promotional materials aligning with Global Advertising & Promotion Compliance team.
- Create and manage the translated approved JPIs and share it with relevant global dept.
- Lead the interaction and communication with the local HAs regarding labeling post -approval and serving as a contact person for 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 JRLs when it is necessary.
- Coordinate with Global Labeling team.
- Lead Japan Regluatory activities mainly labeling with post approbal products other than PMS.
- Get enagged in the Submission sub-team as a Japan labeling lead and join the Global Regulatory Affairs sub team according to scope of discussion.
- Manage PMDA website for pharmaceutical companies
- Operate xMAGIC (multi-outsource documentum system to create e-labeling PDF and XML)
Qualifications
More than 3 years' experiences of JPI in Regulatory Affairs or equivalent knowledge and experience.
Education
- BA/BS degree (or equivalent) in life sciences (medical, pharmacy, veterinary medicine, science, engineering, agriculture, medical economics etc)
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