Job Description
We are seeking a professional to join the Regulatory Affairs staff in the Global Research & Development Division and contribute to CMC regulatory work for biopharmaceuticals and vaccines, from the start of new drug development through regulatory submission and approval, to dosage form additions and change management. There are broad opportunities to work at the forefront of product development using cutting-edge CMC technologies and to take part in discussions on CMC regulatory topics that are attracting attention in the pharmaceutical industry.
- Work with CMC regulatory staff at the U.S. headquarters and other sites to appropriately advance the CMC development stage of assigned products, and prepare the CMC sections of logical, scientifically high-quality regulatory submission documents (manufacturing methods, specifications and test methods, stability, etc.).
- Identify CMC-related issues for products, perform risk assessments, and develop corresponding countermeasures.
- Provide CMC regulatory information obtained from regulatory authorities or industry associations to domestic and overseas related departments and hold discussions.
- Evaluate CMC-related change information and take appropriate regulatory actions as needed.
- Respond appropriately to inquiries during regulatory consultations or approval reviews, and negotiate as necessary.
- Collaborate with stakeholders at the U.S. headquarters or overseas sites during overseas business trips and teleconferences to develop strategic responses to CMC-related matters.
Required qualifications and skills
- Practical experience in drug substance, drug product, or analytical work at CMC laboratories or pilot plants, or practical CMC regulatory experience
- Master's degree or higher in medicine, pharmacy, chemistry, biology, or similar fields
- Practical English conversation skills (TOEIC 700 or higher)
Preferred qualifications and skills
- Experience communicating with overseas parties
※ This position will be filled at the R2 or R3 level.
Additional location(s) Compensation Information:
Required Skills:
Action-Oriented, Adverse Event Report, Compliance Investigations, Detail-Oriented, Employee Training Programs, Labeling Compliance, Negotiation, Policy Implementation, Records Retention Management, Regulatory CMC, Regulatory Communications, Regulatory Strategy Development, Regulatory Submissions, Technical Writing
Preferred Skills:
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Current Contingent Workers apply HERE
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
03/31/2027
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