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OPENING AS REGULATORY EXCUTIVE @ GOWRIE HEALTHCARE

Regulatory Executive (Pharmacology)
Gowrie Healthcare Private Limited - Vadodara, Gujarat

JOB DESCRIPTION ROLE: Regulatory Executive SALARY AND BENEFITS: Negotiable REPORTS TO: Regulatory Team Leader LOCATION: Vadodara JOB TIMING: 12: 00 P.M. to 9:00 P.M. PRIMARY RESPONSIBILITIES To find out the references regarding the clinical and non-clinical sections of the dossier Responsible to write the clinical overview and non-clinical overview from the cited references, Should be involve in filing a dossier for Europe market To compile the CTD Modules as per ICH requirement To evaluate BE studies generated by CRO and utilised it to present in clinical overview Should be involves in communication with other teams during filing process for chasing documents and solving regulatory queries ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES Should be Postgraduate in Pharmacy (Pharmacology) Good English and Excellent Communication skill Able to work as per UK timing Should have positive attitude towards work and have a team spirit