Major Accountabilities

• Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in development and ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.

• Contribute to the regulatory activities in day-to-day operations for assigned TA area.

• Lead cross functional communication for preparing and finalizing Japanese labeling for new drugs.

• Take regulatory related actions to maintain post marketing products in Japan.

• Establish goodrelationship with the Japanese HA in responsible projects

• Contribute to the adherence to regulations, guidelines and global/internal procedures.

• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures

• 100% timely delivery of all training requirements including compliance

Education:

• Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required.  Advanced degree (Master Degree, PhD, etc.) prefered.

• Pharmacist license preferred.

Experience/Professional requirement:       

• Demonstrate good presentation skills in delivering clear messages to audience and modifying language and style to meet the needs from audience.

• Understand the drug development/maintenance processes, milestones in the assigned disease area and Novartis procedures for decision board review and approval.

• Understand basic knowledge of Japan regulation

• Possess basic knowledge of global regulatory environment, and contribute to elaborating the project specific  development/regulatory strategy and plan.

• Report and summarize discussions in which RA plays an important role. Good in writing and reading English (e.g. exchange of scientific and technical information by e-mail and generation of scientific and technical documentation).

• Proactively communicate issues and potential solutions.

• Provide updates on current situation, and ensure that the same information is disseminated throughout the organization as needed. Network with others and share information.

• Demonstrate cultural awareness and work in cross cultural environment.

English Skill:

Fluent English as business language.

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Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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