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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**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:
Scientist
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
Manager
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.
- To design future operational framework and improve process
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
- In order to streamline the process, update to current operational practices/design and implementation of new frameworks
REQUIREMENTS:
Experience/Knowledge
- At least 8 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
Skills
- General knowledge of CMC-RA (required), knowledge of GMP-related regulations is desirable
- Ability to accurately assess priorities and collaborate effectively with appropriate stakeholders
- Ability to develop rational regulatory strategies and independently lead their execution
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.
**Required Skills: **
Preferred Skills: