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Regulatory Affairs Ops Specialist II

1 month ago

Round Lake, United States System One Full time

Title :Regulatory Affairs Ops Specialist II

Location :Round Lake, IL or Deerfield, IL

Start : ASAP

Duration: Contract

Summary

Joule has a contract opening for a Regulatory Affairs Ops Specialist II that will be responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of products.

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.

Project management and negotiation skills to manage multiple projects and deadlines

Technical system skills (e.g. word processing, spreadsheets, databases, online research)

Ability to work effectively in multinational/multicultural environment

Ability to identify compliance risks and escalate when necessary

Requirements

Bachelor’s degree or country equivalent in a scientific discipline

exp with drug solutions, FDA and CMC

5 years regulatory experience within a pharmaceutical company

FDA regulations and knowledge

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