
Global Regulatory Affairs Specialist
1 day ago
We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Specialist to support the development and implementation of regulatory strategies for global markets.
Key responsibilities include:
- Develop and implement regulatory strategies to ensure compliance with global regulatory requirements.
- Contribute to Lifecycle Management (LCM) 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 guidance and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for multiple 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.
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 changes considering global regulatory requirements.
- Compilation and submission of Variations/ supplements for various countries as per applicable regulatory guidelines.
Additional Requirements:
- Strong understanding of ICH guidelines and regulatory requirements.
- Excellent communication and collaboration skills.
- Able to work in a fast-paced environment with multiple priorities.
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