Chiyoda Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Regulatory Science

Job Category

Scientific/Technology


All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description


JOB SUMMARY:
To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA).
To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval.

Key Responsibilities

Change control activities for approved drug products as CMC-RA Regulatory Affairs (chemical and biological products)
Conduct regulatory assessment and develop regulatory strategy
Collaborate with global and local stakeholders related to CMC-RA activity in Japan
Prepare, review and conduct QC of the CMC part of the dossier (e.g. manufacturing process, specifications and test methods, and stability) with logical and scientific quality
Prepare and reply to CMC questions from PMDA, and communicate directly with PMDA officials
Conduct GMP inspection related activities
Conduct regulatory consultations
Conduct CRO management if the above activities are outsourced
May be in charge of new drug application

Requirements

Experience/Knowledge

At least 3 – 5 years' experience in CMC related arena in pharmaceutical industry
Experience in change control operations (partial change applications) for post approved products several times
Experience in preparation of CTD and application form several times
Experience in CMC operations for multiple products including chemical products and biological products is desirable (including continuous manufacturing, antibodies, and cell & gene therapy products)
Experience in new drug application is also desirable

Qualification/Certificate

Practical level English skill (TOEIC ≥ 700)
Bachelor, Master, Doctor

< For Internal Applicants>

If you are Japan employee, please read "Internal Application Guideline" in Ask GS.

Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR.

If you are Japan's employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the "Employee Referral Program (ERP)" on the AskGS and you have made a compliant referral.

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