: URGENTLY HIRING REGULATORY AFFAIRS EXECUTIVE FOR PHARMA INDUSTRY LOCATION: BARODA (SAVLI GIDC) EDUCATION: B.Pharm / M.Pharm EXPERIENCE: Minimum 2-3 years SALARY UP TO 18,000 PM (NEGOTIABLE) TECHNICAL AWARENESS: CTD/ACTD Dossier preparation, Clinical Trials, Dossier submission Regulatory Guidelines DMF and CTD format Review of Specifications and COAs Preparation of Stability Reports and Process Validation Reports BMR, BPR Review.
JOB RESPONSIBILITIES: Preparation of CTD as well as ACTD Dossier for ASEAN and African countries as per Guidelines.
Registration of pharmaceuticals products in ASEAN and African countries. Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting. Review of the quality and analytical data as per the pharmacopeia, specification, MOA, batch records, stability, finished product/packaging material data for the purpose of compilation of the dossier. Solving Queries regarding dossier Checking and give comments on artwork of domestic and export market products. Handling & Submitting Documents to Third Party Managing Export Requirements