CMC Expert

Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to join our team and contribute to the approval and maintenance of marketing authorization. If you are ready to take on this exciting role and support the development of our department, we have an open position for a CMC (Chemistry, Manufacturing, and Control) Expert. Read on and apply today for a life-changing career!
 

About the department
The CMC department plays a crucial role in ensuring the approval and maintenance of marketing authorization. Located in Japan, our team works closely with headquarters to develop high-quality documentation and discuss regulatory strategy. We have a collaborative atmosphere, where team members interact effectively with regulatory authorities and external experts. Join us in making a difference in the pharmaceutical industry.
In this position, you will collaborate with the headquarter (HQ) in Denmark to submit CMC regulatory applications in Japan through in-depth discussions. During the application process, you will have the opportunity to travel to the headquarters in Denmark and work directly with the site to draft a response to the application. We maintain a strong and reliable relationship with the headquarters and other regions, working alongside the entire Novo Nordisk global team to ensure prompt and well-established documentation.

The position 
The CMC Expert is in charge of obtaining approval and maintaining marketing authorization by generating high-quality documentation aligned with Regulatory/CMC requirements in Japan and NN standards. Additionally, the CMC Expert is tasked in developing CMC associates in the department and providing support to the line managers.
As a CMC Expert at Novo Nordisk, you will:

• Collaborate with HQ to prepare J-QOS, application sheets, and responses to PMDA/MHLW, ensuring high quality for submission.
• Engage in discussions with HQ regarding regulatory strategy and scientific aspects for various application documents, prioritizing quality.
• Perform review and quality checks on M3 documents, J-QOS, and application sheets prepared by various teams to ensure accountability.
• Contribute to global CMC activities by providing crucial Japanese regulatory information and experiences from other drug developments to HQ in different phases.
• Effectively interact with regulatory authorities, external experts, and scientists, providing valuable feedback to NNAS, CMC/RA staff, and experts within the JP office.

Qualifications

• A Bachelor’s degree or higher in a scientific field is required.
• Native in Japanese and business-level proficiency in English, particularly in reading and writing, are required, with verbal proficiency being preferable.
• Experience in drug development, including knowledge of regulations, or experience in CMC regulatory affairs for pharmaceutical/chemical/biological products is required.
• Experience in more than 5 product applications and/or 5 or more years of experience in CMC regulatory affairs for biopharmaceutical products is preferred. 

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
Upload your CV to our online career page (click on Apply and follow the instructions).
 
Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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