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Regulatory Affairs CMC Intern

msd · Singapore

New
Internship Hybrid Junior 🇬🇧 English
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

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

Questions fréquentes

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Le contrat proposé est un Internship basé à Singapore.
Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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msd

Singapore