Manager, Global Program Regulatory Manager (GPRM) Japan

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.
• Lead regulatory related actions to maintain post marketing products in Japan.
• Establish strong relationship with the Japanese HA and obtaining high credibility in responsible projects.
• Ensure adherence to regulations, guidelines and global/internal procedures as required.
• Represent RA within specific internal discussions across line functions and external industry meetings.
• Mentor RA associates on drug development.
• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
• 100% timely delivery of all training requirements including compliance.

Key performance indicators:

• Achieve planned submission and approval in time in responsible projects.
• Obtain preferable outcomes of PMDA consultation in development phase projects for which the GPRM-J is responsible.
• No critical problem for maintaining post marketing product in responsible projects.
• Fulfil regulatory responsibilities in Japan to the GPT/GBT and RA subteam, and achieve registration with the best possible labeling.

Minimum Requirements:
Work Experience:

• Train and mentor RA members concerning drug development.
• Understand varied knowledge of Japan regulation.
• Possess extensive knowledge of MHLW/PMDA management, structures and organizations, and maintain trustful working relationship with MHLW/PMDA.
• Contribute to discussions on licensing conditions and integrate legal considerations into regulatory strategy.
• Possess extensive scientific knowledge of assigned TA/disease area, and facilitate scientific interactions between experts relevant for drug development/maintenance.
• Address scientific issues across line functions and implement action plans.
• Define internal procedures for complying with effective regulatory requirements and enhancing quality and efficiency of the processes.
• 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.
• Excellent in effectively making presentation to clarify discussion items and raise key points to focus on in English.
• Contribute drug development planning by integrating expertise in the regulatory, legal and business environments.
• Possess extensive knowledge of global regulatory environment, and take appropriate actions to resolve issues identified in the projects that may negatively affect development strategy and progress.

Education :

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

Languages :

• 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? https://www.novartis.com/about/strategy/people-and-culture

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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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