Regulatory Affairs
3 weeks ago
Position Overview:
We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.
Key responsibilities:
- Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
- 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.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Review technical documents from manufacturing sites, including:
- Specifications
- Batch Manufacturing Records
- Process & Analytical Validations
- Batch Analysis Data
- Stability Data
Experience Requirement:
- 3+ years of experience in managing Initial submissions, Variations, and full LCM (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.
- Review of technical documents from manufacturing sites like of 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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