Job Description
As a regulatory affairs staff member in the Global Research & Development Division, we are looking for a professional to contribute to CMC regulatory work for chemical-based new drugs, from the start of development through application and approval, as well as dosage form additions and change management. You will have broad opportunities to be at the forefront of product development incorporating 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 US headquarters and others to appropriately advance the CMC development stage of assigned products, and prepare the CMC sections of approval application documents (manufacturing methods, specifications and test methods, stability, etc.) that are logical, scientifically rigorous, and of high quality.
- Identify CMC issues and risks related to products, and prepare countermeasures.
- Provide CMC regulatory information obtained from regulatory authorities or industry organizations to domestic and overseas departments and discuss it with them.
- Evaluate change information related to CMC and take appropriate regulatory action as needed.
- Respond appropriately to inquiries during regulatory consultations or approval reviews, and negotiate as necessary.
- During overseas business trips and conference calls, collaborate with stakeholders at the US headquarters or overseas sites to develop strategic responses for CMC-related matters.
Required Qualifications and Skills
- Practical experience in formulation analysis work in a CMC laboratory
- Master's degree or higher in medicine, pharmacy, chemistry, biology, or related fields
- Business-level English conversation ability (TOEIC 700 or higher)
Preferred Qualifications and Skills
- Practical experience in CMC regulatory affairs
- Experience communicating with overseas stakeholders
※ This recruitment is for R2 or R3 hires.
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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