RA Sr Specialist - US drugs

Deerfield, IL 60015

Posted: 06/18/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 620278 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 50-64.27/hr **salary will be commensurate with experience

Essential Duties and Responsibilities:


• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain regulatory files in a format consistent with requirements and perform MoH submissions
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to 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
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and SOPs
• Represent or lead Regulatory Affairs in small project teams

Qualifications:

• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op

Bachelors degree or country equivalent in a scientific discipline
Minimum of 3 years regulatory experience in drugs within a pharmaceutical company, CRO, or similar organization.
Experience in US/FDA regulations and submissions is required, experience in EU and/ or Rest of the world will be a plus.
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About Deerfield, IL

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