
Regulatory Affairs-(LCM Submission)
3 weeks ago
Key Responsibilities
- Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Review technical documents from manufacturing sites, including:
- Specifications
- Batch Manufacturing Records
- Process & Analytical Validations
- Batch Analysis Data
- Stability Data
- Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries .
- 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 US/EU/SA/WHO/ANZ/Other countries.
- Oversee regulatory assessment tasks necessary for life cycle management of products.
Required Skills & Experience
- 2–4 years of experience in pre-approval and post-approval regulatory activities .
- Strong knowledge of ICH guidelines and regulatory frameworks for multiple regions.
- Hands-on experience in dossier compilation and submission for global markets.
- Proven track record in CMC change evaluation and regulatory strategy formulation.
- Familiarity with life cycle management processes in the pharmaceutical/biotech sector.
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