Graduate Intern – CMC RA, Delivery, Small Molecules Mature Products
Job Description
About the Role
Authors multiple CMC technical regulatory documents to support applications for marketing authorization, lifecycle activities, and maintenance of registered products in accordance with the applicable regulatory and scientific standards.
Use digital platforms (e.g. RIM, structured data tools) to execute regulatory activities and ensure high quality regulatory data.
Responsibilities
- Ensuring data and information packages are fit for purpose.
- Identifies risks associated with submission data and information packages.
- Communicates clearly with line manager to identify issues that have business impact.
- Develops an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products.
What You'll Need
- Business Resilience
- Communication
- Digital Fluency
- Matrix Leadership
- Pharmaceutical Regulatory Compliance
- Policy Advocacy
Resume Tip
Highlight your understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products.
Skills Required
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