Preetham Ns

Background

About Preetham Ns

Regulatory Affairs / Patient safety, Quality Control & Quality Assurance professional with 11 years of experience in pharmaceutical industry. Expertise in developing strategy & driving execution. As a Professional, exposed to critical facets of company business. A creative thinker & self - motivated professional who can bring an innovative approach to difficult regulatory issues. An energetic and enthusiastic person & leader with a reputation for developing strong working relationships and interfacing with every level of organization. Major Skill Sets- • Active Regulatory Project Management in US, EU, CAM CAR, MEA & Asia pacific Markets. • Global Labelling Management (CDS, CPIL & EUQRD). • Regulatory strategy and co-ordination. • Quality assurance and GMP/GLP compliance. • Dossier management. • Additional submissions (Renewal of licenses). • Licence Life cycle management. • Regulatory gap analysis. • Regulatory Intelligence. • Good technical knowledge. • Good negotiations skills. • Crisis Management. • Versatile in using tools and systems.(Gazelle tool – for Artwork Creation - IMCL Database). • Safety reporting to Regulatory Authority.(Appendix XI/CIOMS). • Global Clinical Trials exposure (Phase and Project management. • NDA applications for product registration in India. • Phase IV studies (Post-marketing surveillance). • Drug Import and customs clearance.