
Senior Regulatory Affairs Specialist
13 hours ago
About Our Senior Regulatory Affairs Role
We are seeking an experienced Senior Executive to join our team in a pivotal regulatory affairs function, overseeing finished dosage form products.
- Lead the development and review of product dossiers, ensuring compliance with regulatory requirements.
- Conduct thorough gap analyses to identify areas for improvement and implement effective solutions.
- Provide expert guidance on customer and MOH queries, promoting seamless communication and resolving complex issues.
- Manage the product life cycle, from development to market launch, ensuring timely completion of key milestones.
- Collaborate with cross-functional teams to handle development reports, specifications, COAs, stability protocols, and process validation protocols.
- Diligently document reviews, including specification, STP, analytical method validations, development reports, and validation reports, BMR, BPR, PVP/R, and stability data.
- Oversee re-registration procedures, ensuring all necessary administrative documents are accurately completed.
- Monitor the validity of registrations for Finished Goods and Plant GMPs, ensuring ongoing compliance and accuracy.
Required Skills and Qualifications
Sound and deep knowledge of current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).
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