
Senior Regulatory Affairs Specialist
2 days ago
Regulatory Affairs Expertise
We are seeking a detail-oriented Regulatory Affairs-CMC Professional to support the development of comprehensive regulatory strategies for global markets.
Key Responsibilities:
- Develop and implement Variation documents and evaluate post-approval CMC changes in compliance with international regulatory requirements.
- Contribute to Lifecycle Management (LCM) activities by compiling and reviewing CTD dossier modules.
- Compile initial dossiers (Modules 2 & 3) for various countries including the US, EU, SA, WHO, ANZ, and others.
- 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 various countries.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Experience Requirement:
- At least 3 years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for global markets.
- Must have hands-on experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for various countries.
- Hands on experience in initial dossier compilation for various countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
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