Salary
💰 $160,000 - $200,000 per year
About the role
- Manage regulatory strategy and material approvals for labeling, advertising, and promotion
- Ensure compliance and provide strategic regulatory guidance
- Collaborate with cross-functional teams
- Oversee staff and coordinate regulatory document assembly
- Organize team meetings on management of change controls and labeling supplements
Requirements
- Bachelor's degree in science with 10+ years of broad professional experience in Regulatory Affairs
- Regulatory affairs certified (RAC) preferred
- Demonstrated experience leading and managing regulatory submissions
- Experience in reviewing and approving advertising and promotional materials within a pharmaceutical organization
- Good interpersonal skills and strategic business perspective
- Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America
- Performance-based incentives
- 401k with company match
- Healthcare coverage
- Broad range of other benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory submissionslabeling approvalsadvertising approvalspromotion approvalsdocument assemblychange controlslabeling supplements
Soft skills
interpersonal skillsstrategic business perspectiveleadershipcollaboration
Certifications
Regulatory Affairs Certified (RAC)