Summary
About the Role
Major Accountabilities
For the following activities, lead own products and support/aid manager GPRM-J/GPRM-J for other products to solve complicated issues/problems.
- Developing innovative and high quality regulatory strategies to facilitate regulatory processes in development
- Ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.
- Take regulatory actions to maintain products marketed in Japan.
- Ensure adherence to regulations, guidelines and global/internal procedures as required.
Establish mutual-trust relationship with the Japanese HAs and obtain high credibility.
Leadership and direct/indirect involvement in the industry activities to lead the regulatory discussion in complying with Novartis’s wishes.
Key Performance Indicators
Achieve planned submission and approval score
Obtain preferable outcomes of PMDA consultation in development phase projects
No critical problem for maintaining post marketing products
Fulfill regulatory responsibilities in Japan to the GPT and RA sub-team, and support manager GPRM-J/GPRM-J to achieve registration with the best possible labeling
Issue the Japanese regulations/requirements which Novartis’s wishes are reflected
Work Experience
1. 10 years or more experience in pharmaceutical industry, and demonstrate extensive knowledge in drug development/maintenance and global regulatory environment.
2. Possess extensive knowledge of Japanese regulation and enough skills beyond own TA to apply the knowledge into actual product development and maintenance of post marketing product.
3. Integrate scientific issues from a regulatory standpoint across line functions to generate development options.
4. Provide advices to senior management and advocate a course of actions assessing the potential impact of emerging pharmaceutical affairs law, regulations and guidelines affecting Novartis pipeline and portfolio.
5. Possess extensive knowledge of the Japanese HAs management, structures and organizations, and maintain trustful working relationship with the Japanese HAs.
6. Possess extensive scientific knowledge of RA Unit.
7. Coach manager GPRM-J/GPRM-J on drug development.
8. Contribute to discussions on licensing conditions and integrate legal considerations into regulatory strategy.
9. Define internal procedures for complying with effective regulatory requirements and enhancing quality and efficiency of the processes.
10. Effectively negotiate with cross functional teams and lead an agreement in the optimal solution, and manage internal/external negotiation on development strategies and business critical issues.
11. Discuss local regulatory strategies at global level in English.
12. Contribute drug development planning by integrating expertise in the regulatory, legal and business environments.
13. Have the ability to participate in industry group activities as a representative of the Novartis Japan, and ex-press opinions positively and lead the industry's other members.
Language
Fluent English as business language
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