
Global Regulatory Compliance Expert
23 hours ago
Job Summary:
The Regulatory Affairs Specialist will be responsible for managing initial submissions, variations, and full Lifecycle Management (LCM) deliverables for global markets. The ideal candidate will have a strong understanding of regulatory guidelines and experience with Veeva Vault RIM.
Key Responsibilities:
- Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to 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 strategies and conduct evaluations of post-approval CMC 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 & analytical validations, batch analysis data, and stability data.
Experience Requirement:
- At least 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.
Required Skills and Qualifications:
- Regulatory affairs expertise.
- Knowledge of Veeva Vault RIM.
- Strong understanding of ICH guidelines and regulatory guidelines for various countries.
- Excellent communication and project management skills.
- Ability to work in a fast-paced environment.
Benefits:
This role offers a unique opportunity to work in a dynamic industry and contribute to the development of innovative products.
How to Apply:
If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application today.
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