Associate Director, Regulatory Affairs – Advertising and Promotion
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Associate Director guiding FDA advertising and promotion compliance for Definium Therapeutics, a biopharmaceutical company developing psychedelic treatments. Leading promotional review, FDA interactions, submissions, and MLR strategy.
Responsibilities:
- Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned product(s), providing regulatory advice and solutions to reconcile comments on draft promotional materials
- Review and approve promotional and medical materials in Definium’s PromoMats system
- Review and approve social media posts
- Liaise with OPDP/APLB (FDA) as the company’s point of contact on advertising and promotional materials
- Manage OPDP/APLB interactions, regulatory inquiries, advisory-comment submissions, and discussions with FDA staff
- Ensure timely and accurate FDA 2253 submissions of US promotional materials
- Ensure prescribing-information changes are reflected in promotional and advertising materials
- Develop processes and standards for promotional materials and related activities
- Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, company policy, and PRC processes
- Provide regulatory guidance during promotional plan development from concept through field implementation and lead MLR review activities
Requirements:
- Minimum BS in scientific discipline; advanced degree in science preferred
- Minimum 8 years’ experience in the pharmaceutical industry, including at least 5 years in regulatory affairs
- Expert knowledge of advertising and promotion regulations and FDA Guidance documents
- Technical experience in aspects of drug development and labeling
- Solid experience supporting promotional and medical review for product communications
- Experience working with FDA OPDP and APLB on advertising and promotion matters
- Experience in CNS is a plus
- Experience in Veeva PromoMats is a strong plus
Benefits:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave
- Some fun fringe perks
- Additional compensation, including bonus and equity, may be available
Similar Jobs
Senior Director, Global Risk and Compliance
NVIDIA Senior Director leading global risk and compliance for AI infrastructure. Developing strategies, managing compliance teams, and advising leadership on risk mitigation.
Chief Compliance Officer – US
Chief Compliance Officer building SEC registration, policies, and governance for Allocator One’s private-markets fund platform. Advising fund structuring and GP onboarding across Infra One’s US operating platform.
Compliance & Certifications Associate
Compliance associate building ISO 27001, SOC 2, governance, and vendor-risk processes for Credibur’s non-bank lending platform. Supporting regulatory reporting and legal operations as the fintech scales.
Compliance Specialist – RIA
Compliance Specialist reviewing investor-facing marketing and administering AI governance for Ritholtz Wealth Management, a registered investment advisory firm. Supporting regulatory testing, vendor due diligence, books and records, and compliance operations.
Associate Director – Ethics & Compliance, Post Government Employment, COI Review
Associate Director leading ethics, compliance, and conflict-of-interest reviews for RTX, a global aerospace and defense company. Advising leaders, improving compliance programs, and managing post-government employment restrictions across Collins Aerospace.
Senior Governance, Risk, Compliance Analyst
Senior GRC Analyst evaluating cybersecurity controls, privacy, and enterprise risk for Arctic Wolf’s security operations platform. Leading assurance reviews and compliance improvements across global cross-functional teams.
Associate Director – Ethics & Compliance, Post Government Employment and COI Review
Associate Director leading ethics, compliance, conflict-of-interest, and post-government employment reviews at RTX, an aerospace and defense company. Advising leaders, improving compliance processes, and analyzing enterprise risk trends.
Senior Compliance Analyst
Senior Compliance Analyst investigating suspicious activity and high-risk customers for NALA, a global consumer and B2B payments company. Leading SARs, regulatory responses, transaction analysis, and financial crime risk controls.
Software Compliance and Legalization Promotion Specialist
Software compliance specialist promoting licensing compliance and anti-piracy for Ruvixx, a San Francisco SaaS platform protecting intellectual property and brands. Communicating with customers and supporting compliance strategy execution.
Director, Regulatory Response and Examination Management
Director leading regulatory examinations, inquiries, and enforcement responses for SunStrong Management’s solar asset portfolios. Building scalable readiness, documentation, compliance, and remediation programs.
Security & Compliance Manager
Security and compliance manager maintaining SOC 2 and leading ISO 27001 for Relocity’s AI-driven mobility platform. Strengthening privacy, governance, risk management, and data protection across the remote United States team.
Senior Director, Compliance and Privacy
Senior Director leading healthcare compliance, regulatory auditing, and HIPAA privacy programs for American Health Plans. Overseeing risk assessments, investigations, training, audits, and regulatory readiness.
Intake Coordinator – Ethics & Compliance Operations
Intake Coordinator processing confidential ethics and compliance reports for Activision Blizzard, an interactive entertainment company. Maintaining case records, conducting intake conversations, and supporting investigations operations.
GMP QC Compliance Specialist
Senior QC compliance specialist guiding GMP, audits, QMS, data integrity, and regulatory submissions for Pace’s mRNA and biologics laboratories. Supporting safer, healthier outcomes through scientific laboratory services.
Regulatory and Reimbursement Coordinator
Regulatory and reimbursement coordinator managing Medicare, Medicaid, and BlueCross cost reporting for Mercyhealth. Supporting governmental compliance, budgets, reimbursements, audits, and financial performance analysis.
Risk and Compliance Manager
Risk and Compliance Manager overseeing marketing compliance for Marqeta’s embedded finance platform. Reviewing campaigns, advising product teams, and managing regulatory risk across US and Canadian operations.
Senior Regulatory and Start Up Specialist, Brazil
Senior regulatory specialist managing clinical-trial submissions and site activation for Precision for Medicine in Brazil. Supporting compliance, essential documents, contracts, and country start-up activities.
Senior Regulatory and Start Up Specialist, Brazil
Senior regulatory specialist launching clinical trial sites in Brazil for Precision Medicine Group. Managing submissions, essential documents, site activation, and local regulatory compliance.
Regulatory Analyst
Regulatory Analyst translating European climate and carbon-market policy into actionable trading opportunities for Targray. Supporting environmental commodities decisions through regulatory research, analytics, and compliance-credit frameworks.
Regulatory Analyst
Regulatory Analyst translating European climate and renewable-energy policy into actionable carbon-market insights for Targray. Supporting traders with compliance frameworks, credit opportunities, and regulatory-risk analysis.