
Regulatory Affairs Expert
2 days ago
We are seeking a skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.
The successful candidate will be responsible for preparing variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements.
- Compile initial dossiers (Modules 2 & 3) for various countries, including the US, EU, SA, WHO, ANZ, and others.
- Develop regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for multiple countries.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
To be successful in this role, you will need:
- A minimum of 3 years of experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for global markets.
- Hands-on experience with Veeva Vault RIM is essential.
- Proficiency in ICH guidelines and regulatory guidelines for various countries is required.
As a Regulatory Affairs Specialist, you will have the opportunity to work on exciting projects and develop your skills in a dynamic environment.
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