Job Information
System One Regulatory Affairs Ops Specialist II in Round Lake, Illinois
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.