Regulatory Affairs CMC Intern
msd · Singapore
Job description
About the role
Join a global pharmaceutical leader and gain hands‑on experience in regulatory affairs within the CMC (Chemistry, Manufacturing & Controls) area. You will work on APAC region submissions, develop regulatory strategies and collaborate with a diverse, inclusive team focused on delivering life‑changing medicines.
Key responsibilities
- Execute and manage APAC new product registrations and life‑cycle submissions to keep products compliant.
- Generate regulatory strategies and review submission packages.
- Liaise with global colleagues to ensure alignment across regions.
- Support operational‑excellence projects and develop best practices for regulatory science.
- Learn and apply regulatory policy, advocacy and provide ad‑hoc support as needed.
Required profile
- Minimum Diploma or BSc in a scientific discipline (e.g., chemistry, biology, engineering, pharmacy, biochemistry).
- Fluency in an additional APAC language is a plus.
- Strong analytical skills and attention to detail.
Required skills
- Analytical Problem Solving
- Analytical Thinking
- Analytical Tools
- Audits Compliance
- Biology
- Chemical Engineering
- Compliance Investigations
- Data Quality Assurance
- Documentation Standards
- Document Control Systems
- Electronic Common Technical Document (eCTD)
- Liaison Work
- Policy Implementation
- Records Retention Management
- Regulatory Affairs Management
- Regulatory CMC
- Regulatory Communications
- Regulatory Documents
- Regulatory Management
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Published 2 hours ago
Expires 1 month from now
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msd
Singapore
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