Senior Regulatory Consultant – Advertising & Promotion
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Regulatory Consultant leading FDA regulatory strategy for advertising and promotion compliance. Collaborating with cross-functional teams to ensure effective healthcare communications while mitigating risk.
Responsibilities:
- Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
- Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
- Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
- Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
- Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
- Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
- Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
- Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
- Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
- Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders
- Mentor junior team members and contribute to building organizational regulatory capability
Requirements:
- 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
- Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
- Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
- Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
- Demonstrated ability to independently review promotional materials and make sound regulatory decisions
- Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
- Excellent communication, influence, and stakeholder management skills
- Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Similar Jobs
Senior Regulatory Affairs Associate – Clinical Trial Application
Clinical Trial Submission Lead managing and executing Clinical Trial Applications globally. Ensuring compliant submissions across multiple studies with effective team collaboration and stakeholder engagement.
Compliance Support Associate
Agiloft & ComplianceWire Support Associate providing operational support for compliance workflows in regulated life sciences. Requires experience with AgileLoft and ComplianceWire platforms.
Site Activation Specialist II – Min 2 years of regulatory experience in Mexico
Site Activation Specialist responsible for quality deliverables in clinical trials and regulatory compliance in Mexico. Collaborating with cross-functional teams to manage timelines and submission processes for trial activations.
Risk & Compliance Director
Risk & Compliance Director overseeing risk management and compliance programs at JLL. Collaborating with teams to safeguard financial integrity and promote compliance culture.
Customs Compliance Specialist
Customs Compliance Specialist supporting QVC Group and ensuring US import compliance through adherence to trade regulations. Collaborating with internal teams, external partners, and government agencies in a remote role.
GRC & Client Assurance Manager
GRC Manager building and strengthening compliance functions for a B2B SaaS company. Ensuring robust governance while meeting enterprise customer expectations in regulated sectors.
Compliance Specialist
Digital Marketing Specialist managing global advertising campaigns across Google Ads and Facebook Ads. Analyzing performance metrics and optimizing campaigns for international markets with cross-timezone collaboration.
Resident Compliance Specialist
Resident Compliance Specialist in Contract Management Services, fostering communication between residents and owners. Advocating for solutions and ensuring compliance with housing regulations.
PWA Compliance Liaison
PWA Compliance Liaison supporting IRA/PWA compliance at the project/site level. Enhancing visibility and issue resolution for compliance within construction schedules and trade partners.
Senior Compliance Analyst
Providing compliance support to ARI’s life insurance and annuity business. Reviewing marketing materials and ensuring compliance with regulations while collaborating across teams.
Senior Compliance Associate
Senior Compliance Associate leading regulatory reporting and examinations for multi-state mortgage lending. Managing compliance with evolving digital asset regulations in a fintech environment.
Hospice Clinical Compliance & Audit Associate Director
Hospice Clinical Compliance & Audit Associate Director at Ennoble Care overseeing hospice intake compliance and audit activities for regulatory adherence. Ensuring documentation accuracy, compliance, and claim readiness.
Senior GRC Analyst, SOC 2
Senior GRC Analyst I responsible for SOC 2 readiness and compliance. Leading client engagements and coaching team members on SOC 2 automation platforms.
Director of Policy and Regulatory Affairs
Director of Policy at XYPN advocating for fiduciary financial planning regulations and developing member education. Monitoring regulatory changes and influencing advocacy initiatives across the United States.
Regulatory Specialist
Product Regulatory Specialist at J.R. Simplot Company overseeing regulatory compliance of pesticide products. Collaborating with teams to maintain product registrations and safety documentation.
Senior GRC Analyst
Senior GRC Analyst at Bamboo Health improving compliance and security automation. Evaluating risks and conducting audits to enhance the security posture and customer trust.
Compliance Director
Compliance Director providing enterprise-wide compliance leadership for healthcare initiatives at Bon Secours Mercy Health. Responsible for compliance monitoring, risk assessments, and regulatory readiness.
Principal Compliance Consultant – Data Integrity
Principal Compliance Consultant leveraging FDA experience to drive compliance strategies and solutions for life sciences clients. Leading inspections, advising on regulations, and mentoring teams in a collaborative environment.
Middle School Special Education Teacher
Special Education Teacher managing IEPs and supporting students online at Stride. Collaborating with families and staff to ensure adapted education and successful learning outcomes.
Telecom Regulatory Compliance Specialist
Telecom Regulatory Compliance Specialist for telecommunications providers ensuring compliance filings. Advancing broadband initiatives while working remotely in a mission-driven organization.