Job Description

CMC Expert
CMRQ
Tokyo, Japan

 

Join our dynamic team as a CMC ( chemistry, manufacturing, and controls ) Expert, where you will play a pivotal role in shaping regulatory strategies and ensuring high-quality submissions to authorities like PMDA/MHLW. Leverage your expertise to collaborate with global teams, sharing valuable insights from drug development projects. If you're passionate about driving innovation in the pharmaceutical industry and making a lasting impact, we want to hear from you!

Your new role
In this role, you will develop and implement comprehensive relationship-building strategies that effectively communicate key messages to target audiences while managing content dissemination for internal and external stakeholders. You will also establish collaboration systems with external vendors, strengthen stakeholder relationships to align with organizational goals, and ensure compliance with Novo Nordisk's branding and editorial standards. 
Your responsibilities will include:

• Prepare high-quality J-QOS documents, application sheets, and responses to inquiries from PMDA/MHLW in collaboration with Headquarters (HQ), while ensuring adherence to regulatory standards.
• Collaborate with HQ to discuss regulatory strategy and scientific considerations related to CMC application documents.
• Conduct reviews and quality control of M3 documents, J-QOS, and application materials prepared by HQ and local experts, supporting their accountability in compliance with regulations.
• Contribute to global CMC activities by sharing important Japanese regulatory information and insights from other drug development projects throughout various phases (development, submission, post-approval, and commercial).
• Engage effectively with regulatory authorities, external experts, and internal departments; provide coaching to CMC associates and RA staff to enhance their professional skills and knowledge.

Your new department
Join Novo Nordisk Japan's Clinical Medical Regulatory Quality (CMRQ) Regulatory Affairs department to play a vital role in ensuring compliance with Japanese regulatory requirements for our innovative products. You will prepare and submit critical documentation for clinical trials and marketing authorizations, engaging directly with regulatory authorities to facilitate smooth communication and strategic oversight. If you are passionate about navigating the regulatory landscape and ensuring high-quality standards in healthcare, we invite you to apply and be part of our mission to improve patient outcomes.

Your skills & qualifications
The ideal candidate for the role should have substantial experience in drug development, including regulatory CMC knowledge and involvement in the approval of multiple product applications. Strong leadership, effective communication, a proactive mindset, and proficiency in both English and Fluency in Japanese are essential for success in this position. You will bring with you:

• Bachelor's degree or higher required, preferably in a medical science or chemistry field.
• +5 years of experience in drug development, including significant knowledge of regulations and pharmaceutical, chemical, or biological laboratory practices, as well as manufacturing processes. Experience in regulatory CMC and involvement in the approval of more than 5 product applications is preferred.
• Strong leadership capabilities, planning skills, problem-solving acumen, team spirit, and effective communication skills.
• A sound business mindset, ethical conduct, openness to new ideas, a proactive approach, readiness for change, and a customer-oriented attitude.
• Proficiency in reading, writing, and speaking English at a business level.

 

Working at Novo Nordisk  
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means that opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

More information 
You are welcome to contact our Japan Talent Acquisition team at JPHCWG_SAIYO@novonordisk.com if you have questions about the role. Be advised that we might not be able to answer queries about your recruitment status.

Deadline
Until the completion of the recruitment. Applications are reviewed on an ongoing basis.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

 

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