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Novartis

Associate or Manager, PHAD Japan

Novartis is hiring an Associate or Manager, PHAD Japan. Level rates it ; you can apply on Novartis.

Level's read on this job

  • Little AI ●○○○ is how Level rates this role: aI is not part of the work.
  • Tools and skills the posting cites include cmc development, pharmaceutical regulations and regulatory submissions.
  • Level classifies it as a senior role.
  • Level lists 864 other open roles at Novartis.

AI in this role

Act as a CMC development specialist to enhance Japan's CMC development strategy and support global and local regulatory submissions.

cmc-developmentpharmaceutical-regulationsregulatory-submissions

Job Description Summary

As a CMC development specialist, enhance Japan’s CMC development strategy by offering scientific and technical support to global/local CMC development teams and other departments, while keeping up with the latest technological advancements.


Job Description

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

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

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

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.

Additional Information

Be aware of fake job advertisements and job offers. Novartis does not make job offers without interviews and never asks candidates for money. All our current job openings are displayed here. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money, or provide personal information.

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Skills Desired

Continual Improvement Process, Master Data, Materials Management, Materials Requirements Planning (MRP), Production Planning, Supply Chain Management (SCM), Supply Chain Planning (SCP), Technical Requirements, Warehouse Management System (WMS), Waterfall Model

How we rate this

Associate or Manager, PHAD Japan at Novartis rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

  1. ●●●● Builds AI80 to 100
  2. ●●●○ Works on AI60 to 79
  3. ●●○○ Uses AI40 to 59
  4. ●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Cmc DevelopmentPharmaceutical RegulationsRegulatory Submissions

Questions you could be asked

  1. Tell me about a project where cmc development was part of your work. What did you do?
  2. Tell me about a project where pharmaceutical regulations was part of your work. What did you do?
  3. Tell me about a project where regulatory submissions was part of your work. What did you do?

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  • List these exact terms on your resume: Cmc Development, Pharmaceutical Regulations, and Regulatory Submissions. An applicant tracking system matches the wording, not the idea.
  • Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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