
Global Regulatory Specialist
2 days ago
We are seeking a highly skilled Regulatory Affairs Associate to support end-to-end submissions for global markets.
- Lifecycle Management Expertise:
- Compile and review CTD dossier modules for Lifecycle Management (LCM) activities.
- Prepare Variation documents and/or evaluate post-approval changes in compliance with global regulatory requirements.
Key Responsibilities:
- Submission Management:
- Compile initial dossiers for US/EU/SA/WHO/ANZ/Others, including Modules 2 & 3.
- Manage submission of Variations/Supplements for global markets.
Requirements:
- Regulatory Experience:
- At least 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Proficient in ICH guidelines and regulatory guidelines for global regions.
Competitive compensation package will be offered to the successful candidate.
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