Company
Pharma
SeniorRegulatoryConsultant–Advertising&Promotion(StrategicLead)
“Senior Regulatory Consultant – Advertising & Promotion (Strategic Lead). Skills: Regulatory advising, FDA regulations, Promotional material review, Risk management. Serve as strategic regulatory advisor. Provide guidance on regulatory scenarios”
Industry & Context.
Critical thinking; Analytical; Problem-solving; Solutions-oriented
What They're Looking For.
Must Have
Bachelor's degree, 7+ years regulatory affairs experience, Focus on advertising and promotion, Deep expertise in FDA regulations, Interpret regulatory guidance, Experience collaborating with Medical Affairs, Experience collaborating with Legal, Experience collaborating with Marketing, Experience collaborating with Commercial teams, Excellent communication skills, Excellent influence skills, Excellent stakeholder management skills, Critical thinking abilities, Analytical abilities, Problem-solving abilities
Nice to Have
Advanced degree preferred, Experience supporting product launches, Experience supporting high-visibility brands, Familiarity with global regulatory environments, Experience with MLR/PRC committee leadership
What You'll Do.
Serve as strategic regulatory advisor
Provide guidance on regulatory scenarios
Review promotional materials
Approve promotional materials
Review non-promotional materials
Approve non-promotional materials
Interpret FDA guidance
Interpret enforcement trends
Interpret regulatory updates
Inform risk management
Influence claims development
Influence communication strategies
Ensure regulatory alignment
Partner with Medical Affairs
Ensure balanced communications
Ensure accurate communications
Ensure scientifically supported communications
Lead promotional review committees
Support promotional review committees
Ensure efficient decision-making
Ensure consistent decision-making
Ensure compliant decision-making
Conduct risk assessments
Develop mitigation strategies
Mentor junior regulatory team members
Support junior regulatory team members
Stay current on regulatory trends
Stay current on FDA warning letters
Stay current on industry best practices
Communicate insights to stakeholders
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Medical Affairs; Legal; Commercial; Marketing; Clinical teams; Senior cross-functional stakeholders; Senior leadership levels
Communication Scope
Stakeholder management; Senior leadership communication
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