Senior Executive / Assistant Manager Regulatory Affairs Job In Sinopharm India Private Limited In Delhi, Gurgaon / Gurugram

Senior Executive / Assistant Manager Regulatory AffairsMandatory Key skillsDrug Regulatory affairs , Knowledge of working with CDSCO department, Registration of import drugJob location: Delhi, GurgaonExperience Range: 2-5 years Industry: Pharmaceuticals , Healthcare Salary Range: 4 to 7 Lakhs YOUR RESPONSIBILITIESa) Review and compilation of dossier ( CTD/ACTD), Drug Master File ,Plant Master File and all other dossiers as per the regulatory guidelinesb) Coordination With different manufacturers and other colleagues for collecting the technical and administrative documents to compile dossier for submission in CDSCOc) Reviewing various technical reports like specifications and analytical procedures, stability data , QC analysis reports for various pharmaceuticals formulations, Biological Products / APId) Preparation of regulatory documents viz Form 40, CT 18, Form 8, Form9,and other documents in schedule DI, Schedule DII etc.

e) Coordination with CDSCO and submit the regular updates and develop the relationship with the key officersf) Prepare, Review and periodically amend package inserts /Leaflets and product label and artworks and any other task in compliance with the Indian regulationg) Monitoring regulatory agency's websites for updates, gathering information on regulations updateh) Operate the website and CDSCO portal to submit all the application for various products and queries on timely basis.

i) Do the research on niche/emerging molecule/molecule high in demand and discuss with management to register the productsj) Put all the efforts to register maximum products to benefit the organization /all theEducation must be Bachelor of Pharmacy

Sinopharm India Private Limited is looking for .

Sinopharm India Private Limited is looking for Any Graduate / Post Graduate profile candidates.