
Regulatory Compliance Specialist
1 week ago
Job Overview:
We are seeking a skilled Regulatory Compliance Specialist to support end-to-end submissions for global markets. Required experience includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.
Key Responsibilities- Variation Documents and CMC Changes: Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Lifecycle Management (LCM) Activities: Contribute to LCM activities by helping to compile and review CTD dossier modules.
- Initial Dossiers: Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
- Regulatory Strategies: Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Variations/Submissions: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
- Query and Submission Workflows: Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Technical Document Review: Review technical documents from manufacturing sites, including Specifications, Batch Manufacturing Records, Process & Analytical Validations, Batch Analysis Data, and Stability Data.
- 3+ years of experience in managing Initial submissions, Variations, and full LCM 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.
- Review of technical documents from manufacturing sites like Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.
- 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.
- Compilation and submission of Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
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