Regulatory Affairs Ops Specialist II

Round Lake, Illinois

Employer: System One Holdings, LLC
Industry: 
Salary: $30 - $39 per hour
Job type: Full-Time
Regulatory Affairs Ops Specialist II

6 month contract

$30-39/hour

Description:

M-F 8 - 5

Remote is an option but Onsite Preferred

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

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Knowledge of regulations
  • Scientific knowledge
  • Project management skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Strong negotiation skills
  • 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

Education and/or Experience:
  • Bachelor's degree or country equivalent in a scientific discipline
  • Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization.
  • FDA regulations and knowledge
Created: 2024-06-19
Reference: 321503
Country: United States
State: Illinois
City: Round Lake

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