Regulatory Affairs Ops Specialist II
Round Lake, Illinois
Experience: 3
Category: Scientific & Clinical
Brand: Joulé
Compensation Range: 30.00 - 39.00 Per Hour
Job ID: 321503
Date Posted: 06/18/2024
Shortcut: http://jobs.systemone.com/XoOJh1
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
- 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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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