BriefCase
BriefCase

Junior Regulatory Affairs Associate Job in Parexel International Corporation

Junior Regulatory Affairs Associate

Parexel International Corporation 4+ weeks ago
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Job Summary

Responsibilities

Candidate will need to interact with scientists to discuss report requirements and co-ordinate report availability and their own availability to author the non-clinical sections of respective documents in order to meet deadlines for regulatory submission.
-should have a sound working knowledge of the 3 disciplines: pharmacology, pharmacokinetics or toxicology and understand how they interact to support the understanding of the drug product profile

-Candidateshould have experience with the authoring of the non-clinical components of an Investigator s Brochure/Non-clinical overviews/Written and tabulated summaries to support EU and/or US submissions (or other international markets).
-Have experience with the writing or reviewing of scientific reports and/or publications and pay close attention to detail

Candidate should have experience with new active substances; not limited to generic submissions.


Qualifications

M. Pharma Pharmacology from a reputed Institute with 5-8 years of relevant and hands on experience working with pharma majors. Apply Now Save Job
Experience Required :

Fresher

Vacancy :

2 - 4 Hires

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