
Senior Regulatory Affairs Specialist
2 days ago
Job Title: Regulatory Affairs Associate
Job Overview:
- We seek a detail-oriented RA-CMC professional to support end-to-end submissions for global markets.
- This role involves exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.
- Document Preparation: Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Lifecycle Management: Contribute to Lifecycle Management (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.
- Submission Management: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
- Query Tracking: Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Document Review: Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.
- Minimum Experience: 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
- Veeva Vault RIM: Must have experience with Veeva Vault RIM.
- Regulatory Guidelines: Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
- Technical Document Review: Review of technical documents from manufacturing sites like specifications, batch manufacturing records, validations, batch analysis data, and stability etc. required for compilation of dossier sections/Variations.
- Initial Dossier Compilation: Hands on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
- Regulatory Strategy Evaluation: Experience in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
- Variation/Submission: Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
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