Regulatory Associate (5-7 Years Experience)
Shift: Monday-Friday 8:00am - 5:00pm
Location: Indianapolis, IN 46285
Requirements: BS Degree and 5+ years Regulatory experience with global submission work with at least 2+ years Pharma experience (device or pharmaceutical). Other requirements include: Excel and Powerpoint
Description: Management of Regulatory Submissions. Leading cross functional team discussions regarding Regulatory submissions
Handles adverse event reports from scientific literature by collecting, reviewing, and entering global adverse events reports; routes applicable literature on adverse event cases to the appropriate clinical safety physician for review.
Provides support to global personnel regarding Global Product Safety policies, processes and procedures by updating SOPs, training tools/programs as necessary. Ensures regulatory compliance for expedited submission of case reports to regulatory authorities.
Collaborates 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).