Officer - Regulatory Affairs Mumbai.."R"

Officer - Regulatory Affairs
Titan Laboratories Pvt. Ltd - Mumbai, Maharashtra

Candidate should have complete knowledge of 1. Hands on experience in Clinical Trial Applications (CTA), Clinical study report preparation. 2. Preparation of Replies to Questions and Compliance reports to regulatory authorities viz. EMEA, MHRA, FDA. 3. Excellent Leadership qualities with strong analytical, problem solving and interpersonal skills 4. Solid Project Management experience coupled with good exposure to R&D and entrepreneurial abilities to set up companies regulatory affairs department 5. In depth knowledge in Preparation and filing CTD dossier in EU & UKMHRA 6. experience of ANVISA,, Brazil and ICH/EU guidelines Salary: INR 1,50,000 - 3,75,000 P.A. Exp. of EU & Brazil Market Industry: Pharma / Biotech / Clinical Research Functional Area: Legal, Regulatory, Intellectual Property Role Category: Drug Regulatory Affairs/Documentation Role: Regulatory Affairs Manager Keyskills: Experience of ANVISA Brazil and ICH /EU guidelines Experience of ANVISA Brazil and ICH /EU guidelinesCLICK HERE TO VIEW/APPLY