Senior Executive

Senior Executive / Assistant Manager Regulatory AffairsMandatory Key skills
Drug Regulatory affairs , Knowledge of working with CDSCO department, Registration of import drug

Job location: Delhi, Gurgaon

Experience Range: 2-5 years

Industry:
Pharmaceuticals , Healthcare

Salary Range: 4 to 7 Lakhs

YOUR RESPONSIBILITIES

a) Review and compilation of dossier ( CTD/ACTD), Drug Master File ,Plant Master File and all other dossiers as per the regulatory guidelines.
b) Coordination With different manufacturers and other colleagues for collecting the technical and administrative documents to compile dossier for submission in CDSCO.
c) Reviewing various technical reports like specifications and analytical procedures, stability data , QC analysis reports for various pharmaceuticals formulations, Biological Products / API.
d) 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 officers.
f) Prepare, Review and periodically amend package inserts /Leaflets and product label and artworks and any other task in compliance with the Indian regulation.
g) Monitoring regulatory agency's websites for updates, gathering information on regulations update.
h) 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 products.
j) Put all the efforts to register maximum products to benefit the organization /all the
Education must be Bachelor of Pharmacy