
Regulatory Affairs Specialist
2 weeks ago
We are seeking a detail-oriented Regulatory Affairs Associate to support submissions for global markets.
Key Responsibilities:- Document Preparation: Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with regulatory requirements.
- Lifecycle Management: Contribute to Lifecycle Management 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 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.
- Document Review: Review technical documents from manufacturing sites, including Specifications, Batch Manufacturing Records, Process & Analytical Validations, Batch Analysis Data, and Stability Data.
- Experience Requirement: 3+ years of experience in managing Initial submissions, Variations, and full LCM 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 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 Strategies 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.
Please note that we require proficiency in multiple regions, including the US, EU, SA, WHO, ANZ, and Other Countries. The ideal candidate should be able to manage submissions across these regions effectively.
In addition to the above requirements, the selected candidate will undergo extensive training on our systems and processes to ensure a smooth onboarding experience.
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