Regulatory Affairs Ops Specialist

6 Months (Extendable)

Round Lake, IL

Max PR: $35-39/hr

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

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

Essential Duties and Responsibilities:

• Initiate and develop complex regulatory project plans
• Identify & prioritize key areas of regulatory risk
• Monitor applicable regulatory requirements
• Create and maintain regulatory files in a format consistent with requirements
• Provide regulatory advice to project teams.
• Respond to complex questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Manage regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and SOP’s
• Lead or represent Regulatory Affairs in project teams
• Provide guidance and coaching for areas of responsibility to lower level team members

Qualifications:

• 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