Regulatory Associate Pharmaceutical

Job Title Regulatory Associate Pharmaceutical

Jobid US33YEKB_BH1431485

Location: Indianapolis, IN, 46202, USA

Description Senior level Regulatory Associate position available with a pharmaceutical company in the Indianapolis area.

We are looking to hire someone with regulatory experience in medical device, biotech or with a pharmaceutical company

Long term contract position in the Global Safety department, managing adverse event reports from scientific literature.

This position also requires collaboration with internal and external customers to prepare quality periodic/annual safety summary reports; partners with Global Product Safety physicians to maintain and communicate product safety profile analyses to appropriate persons and groups (e. g. regulatory agencies.

Other responsibilities;


+ Provides support to global personnel regarding Global Product Safety policies, processes and procedures by updating SOPs, training tools/programs as necessary
+ Ensure regulatory compliance for expedited submission of case reports to regulatory authorities
+ Document in ECTD Express, an electronic technical document system
5+ years of Regulatory experience with global submission

Bachelor's degree

SharePoint, ECTD Express or Leo experience

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