Contribute to the overall activities in drug development* toward obtaining the marketing authorization and maintenance activities of post marketing products in assigned TA.
About The Role
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.
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 regulationPossess 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.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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 and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.Join our Novartis Network:
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現在の求人情報はすべてこちらに掲載されています。詐欺の可能性がある求人広告や採用オファーに遭遇した場合は、返信したり、金銭や個人情報を送ったりしないよう強くおすすめします。
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally:
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