Career Biotech


R
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 

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