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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in US Regulatory Affairs with a focus on advertising and promotion, ensuring compliance with FDA regulations while effectively managing cross-functional communication and collaboration. Possesses strong analytical skills to assess regulatory risks and develop compliant strategies for consumer-facing communications.
Highest-signal resume keywords
Regulatory Affairs ExperienceFDA Advertising And Promotion RequirementsDTC Promotional ReviewCross-Functional CollaborationRegulatory Risk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsAdvertising And PromotionFDA CompliancePromotional Material ReviewScientific Data InterpretationConsumer-Facing Claims AssessmentLifecycle ManagementLaunch PlanningRegulatory Risk CommunicationDTC Concepts Guidance
Soft Skills
Attention To DetailOrganizational SkillsOral CommunicationWritten CommunicationJudgment
Certifications & Qualifications
Accredited Bachelor's Degree
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryMedical Review ForumsConsumer CommunicationsAdvertising Review Processes
About the role
Key responsibilities & impact- Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities
- Lead regulatory support for DTC print, digital, social media, and other consumer-facing communications
- Review promotional materials for accuracy, consistency with approved labeling, and FDA compliance
- Represent Regulatory Affairs in Medical, Legal and Regulatory review forums
- Identify regulatory risks, negotiate positions, and propose compliant solutions
- Provide guidance on DTC concepts and communication strategies, including television, digital, social, patient, and advocacy campaigns
- Support HCP promotional communications and scientific exchange activities
- Support launch planning and lifecycle management, including launch material reviews and timeline coordination
- Monitor FDA regulations, guidance, enforcement activities, and industry trends
- Contribute to improvements in advertising and promotional review processes
- Share subject-matter expertise and best practices with Regulatory Affairs and cross-functional partners
Requirements
What you’ll need- Accredited bachelor’s degree
- 5+ years of experience in Regulatory Affairs, R&D, or a related area within the pharmaceutical or biotechnology industry
- 2 years of direct advertising and promotion experience or closely applicable Regulatory expertise
- Working knowledge of US FDA advertising and promotion requirements
- Experience reviewing and interpreting customer communications
- Hands-on experience with DTC promotional review
- Ability to assess consumer-facing claims, presentations, and supporting scientific evidence
- Understanding of scientific data and promotional regulations relating to drugs and/or biologics
- Experience identifying and communicating regulatory risk
- Ability to work cross-functionally in multidisciplinary and matrixed teams
- Ability to independently manage assigned work and exercise sound judgment
- Strong attention to detail and organizational skills
- Excellent oral and written communication skills
- Ability to travel up to 20%; international travel may be required
Benefits
Comp & perks- 15% bonus target based on company and individual performance
- Eligibility to participate in the company’s long-term incentive plan
- Flexible paid time off (PTO)
- Medical, Dental and Vision health benefits
- Company match 401k
- Reasonable accommodations during the employment application process
