
Global Regulatory Affairs Expert
2 days ago
We are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.
Key Responsibilities:
- Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to Lifecycle Management activities by helping to compile and review 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 Requirements:
- Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Must have 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.
Job Requirements:
- Strong understanding of international regulations and standards related to Regulatory Affairs.
- Excellent communication skills and ability to work effectively in a team environment.
- Ability to prioritize tasks and meet deadlines.
What We Offer:
- A competitive salary package.
- A dynamic and supportive work environment.
- The opportunity to work with a talented team of professionals.
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