Associate or Manager, PHAD Japan

Key Responsibilities

• Act as a subject matter expert (SME) on CMC development within the TRD submission team, from initiating clinical trials through NDA filings.

• Understand CMC development strategies for assigned projects and provide scientific and technical insights on potential risks, particularly for novel and complex elements.

• Develop expertise in new modalities and technologies, including formulations, process development, manufacturing and control strategies, and provide expert consultation.

• Provide input on Japanese requirements and expectations, and collaborate with local and global stakeholders to address scientific and technical challenges.

• Review and prepare documents, protocols and reports required for Japan filings and launches, including J-NDA Module 3 and J-QOS.

• Act as a CMC expert supporting other functions, including knowledge sharing, data generation for marketed products, and collaboration with clinical and commercial stakeholders.

• Maintain global and local development-related SOPs and manuals, and perform QC activities for investigational medicinal product (IMP) release in Japan.

• Ensure compliance with company requirements and, for manager-level positions, mentor associates and lead activities within PHAD Japan.

Background

Education: University or graduate (master's) degree (or higher) in pharmacy, science, engineering, or other technical fields.

Essential Requirements

• University or graduate (master’s) degree or higher in pharmacy, science, engineering or another technical field.

• Expertise in at least one CMC area, such as drug substance, drug product, formulation development, process development, setting control strategy or analytical science.

• Basic knowledge of Japanese pharmaceutical regulations.

• Native-level proficiency in Japanese.

• Proficiency in reading and writing in English.

Desirable Requirements

• Preferably 5+ years of experience in the pharmaceutical industry.

• Intermediate business-level speaking and listening skills in English.

* You do not need to be familiar with all the modalities or technical area mentioned in the Major Accountabilities section. If you have specialized skills in any CMC area and a strong motivation to learn about other technical field, we encourage you to apply.

Language skill: Native-level proficiency in Japanese is required, proficiency in reading and writing in English is necessary, and intermediate business-level speaking and listening skills in English are preferred.

* If the candidate possesses exceptional CMC skills, the English language requirements mentioned above can be flexible and open to discussion.

Benefits and Rewards

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Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

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