
Global Regulatory Affairs Specialist
1 day ago
Job Title: Regulatory Affairs Specialist
We are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.
- The ideal candidate will have experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for the global markets.
About the Role:
The Regulatory Affairs specialist 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 US / EU / SA / WHO / ANZ / Other Countries.
- Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
Key Responsibilities:
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Requirements:
- 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for the global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
- Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
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