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Job Description
Regulatory Officer jobs in Vadodara
Education :B.PHARM;B.PHARM
Experience :2-9 Years
Industry
Work Time :
Salary : 20000 /- Per Month
Incentive
Language Known :
Phone : +9198********
Email : ****@*****.com
Website : www.******.com
: 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
Skills
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