
Global Regulatory Affairs Professional
2 days ago
**Regulatory Affairs Expert Wanted**
We are seeking a highly skilled Regulatory Affairs Specialist to join our global team.
**Job Overview**
- Prepare and evaluate regulatory submissions, ensuring compliance with international guidelines and regulations.
- Contribute to the development of lifecycle management strategies, coordinating with cross-functional teams to deliver high-quality CTD dossier modules.
- Compile initial dossiers for US / EU / SA / WHO / ANZ / Other Countries, incorporating market-specific requirements and regulatory nuances.
- Provide regulatory expertise, conducting evaluations of post-approval changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for global markets, leveraging Veeva Vault RIM to track queries and manage workflows.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
**Key Qualifications**
- At least 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Proven expertise with Veeva Vault RIM.
- Strong understanding of ICH guidelines and regulatory requirements for US/EU/SA/WHO/ANZ/Other countries.
- Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
- Ability to provide Regulatory strategies and Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
- Experience in compiling and submitting Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
**What We Offer**
A dynamic work environment with opportunities for professional growth and development.
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