Sandesh Charaikar

About Sandesh Charaikar

Regulatory Affairs professional with around 20+ years of experience in Indian and International regulatory Affairs.Presently working as Manager (Regulatory Affairs) with Merck Group.Skilled in defining and implementing regulatory pathways and project management including CMC co-ordination for various categories of products like Drug Products (INDs & NCEs), Cosmetic Products, Medical Devices, consumer health products and Special products Stem Cell Based products.Job competencies • Hands on experience in regulatory strategy planning for new and ongoing projects.• Expertise in effective liasioning with Government bodies for timely approvals in India• Experience in obtaining following certificates/ Licenses in India- Test License- Manufacturing License- GMP & COPP- FSC- No conviction certificate- Manufacturing and Marketing certificate- Import License- Export NOCs- NOCs for New Products• Hands on experience in Filing and approvals of IND, NDA and SNDA in India• Hands on experience in planning regulatory strategy and registration of In-licensing products in India in following categories- Cosmetic products - Medical Devices- Herbal products - Blood products/ component• Hands on experience in regulatory filing for ROW and regulated market for generic products• Knowledge of FSSAI guidelines and applications of licenses for Manufacturing Facility, Registered office, Warehouses and Product Approvals etc.

Experience

1. Manager - Regulatory Affairs (Consumer Health)

   Merck Group

   Feb 2015 — Present

   Overall regulatory compliance for Innovation laboratory, Manage all administrative Interactions with external authorities and consultants.

Education

• Mumbai University

  graduate; Bachelor of Science; Diploma; Diploma, computer programming; DTP Software

  1993

Skills

• Good Laboratory Practice (Glp)
• Regulatory Affairs
• Pharmaceutical Industry
• Sop
• Gmp
• Pharmaceutics