System One is Hiring a Regulatory Affairs Ops Specialist II Near Round Lake, IL
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.