Associate Regulatory Affairs by Synowledge PV Services India Pvt Ltd in Mysore - Walkin Interview on 17th September from 10 AM D4 ift.tt/1taQ7i5 Job Description Send me Jobs like this | Save this Job | Report this Job JOB TITLE: Associate Regulatory Affairs EDUCATION: HEALTHCARE PROFESSIONAL DEGREE (BACHELOR/MASTERS) E.G., B.PHARM,/M.PHARM in Regulatory Affairs ESSENTIAL DUTIES AND RESPONSIBILITIES: Familiarity with FDA, EU and ICH regulations and guidelines. Coordinate and support regulatory submissions to various Health Authorities for various types of applications in various markets including US, EU and RoW regions. Provide administrative support including document compilation, entering information into databases, distribution of regulatory updates to the team Assist and Maintains regulatory systems and databases to support effective implementation of regulatory activities Search and source project relevant scientific content from the published literature as and when required. Set-up and maintain adequate systems for document management and databases. Bookmarking and Hyperlinking of documents for dossier publishing using eCTD tools. OTHER RESPONSIBILITIES AND DESIRED SKILLS: Ability to work in a cross-functional environment between QA and other stakeholders under stringent timelines Good organizational ability and strong attention to detail. Regulatory Certification from a reputed institution Demonstrated competence with regulatory terminology Ability to utilize computer applications packages, such as MS Office, Adobe plugins Eagerness to learn new technologies that support electronic submissions Must be flexible and able to reprioritize according to departmental needs Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. APPLY HERE
Posted on: Wed, 17 Sep 2014 03:19:28 +0000
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