
RA Global Submission Specialist
1 week ago
We are seeking a detail-oriented regulatory affairs professional 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.
Key Responsibilities- Variation Management: Prepare variation documents and evaluate post-approval changes in compliance with global regulatory requirements.
- Lifecycle Management: Contribute to activities by compiling and reviewing 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 changes considering ICH and country-specific guidelines.
- Submission Management: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
- Experience: 3+ years of experience in managing initial submissions, variations, and full 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 Documents: 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: Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries (Module 2 & 3).
- Regulatory Strategies Evaluation: Experience in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
- Submission of Variations: Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
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