Profile Details

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Hire Lini S.

India

USD 90 /hr

Regulatory Affairs Expert with 20 Years Experience (Regulatory and Scientific Writing Services)

Profile Summary

Specialities - Well-versed in EU Registration procedures (DC/MR, CP and nationals). - CMC Dossier Development & writing - Regulatory Strategy - Global strategy for Generic Drugs, New Drugs, Generic fixed dose combinations & biosimilars/biologics for global markets EU, US, TGA, Swiss and other ROW - Regulatory Dossier Due Diligence - Implementation and maintenance of electronic dossier tools - Scientific advice meetings, Briefing packages and controlled correspondence with the regulators - Dossier development for innovative drugs - EU Lifecycle maintenance – All types of variations, renewal, update of product information based on safety updates - CTD/NeeS/eCTD Compilation of dossiers, Review and publishing in electronic format - Documentation and Quality Management Systems - Vendor qualification/assessment, contract validation &business proposal review - Deliverable/Scope of work setting in the pre-sale/Business Development phase and inputs towards business intelligence case studies - Training & Development to business & project management team globally - Project Management

Subject Matter Expertise

• ★ Regulatory Affairs
• ★ CMC Documentation
• ★ Medical Writing
• ☆ Chemistry
• ☆ Biochemistry
• ☆ Pharmaceutical Sciences
• ☆ Biologic & Biosimilar Development
• ☆ Vaccine Development
• ☆ European Medical Device Regulation (MDR)
• ☆ Clinical Trials
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Affairs
• ☆ Product Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Trial Protocol Writing
• ☆ Medical Content Writing
• ☆ Technical & Scientific Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study

Consulting Scientific and Technical Consulting

Product Development Formulation

Work Experience

Senior Regulatory Expert

Silmed Scientific

March 2019 - Present

Education

MSc Pharmaceutical Chemistry

Mahatma Gandhi University

June 2002 - July 2004

Certifications

• Certification details not provided.