Senior Director, Regulatory Affairs – Advertising & Promotion

Job Description:

• Serving as the primary U.S Regulatory expert for promotional materials through reputed company’ pipeline and any future reputed company launches
• Chair and reputed company PRC, ensuring “fair balance,” alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules
• Ensure U.S advertising and promotional strategy consistency with FDCA, FDAMA, FD&C labelling, and OPDP guidance
• Prepare and file pre-clearance materials reputed company reputed company FDA 2253, reputed company OPDP interactions, and respond to enforcement letters/advisories
• Support label negotiations for PI, carton/container, and PPI
• Review advertising copy, promotional claims, speaker programs, digital/reputed company media materials, and HCP-facing promotions for FDA compliance
• Identify and remediate claims, manage recall and mitigation activities reputed company necessary
• Mentor junior RA professionals; reputed company operational delivery and resource allocation
• Manage budget for Ad/Promo activities and ensure cohesive execution across programs

Requirements:

• Bachelors in Life Sciences, Pharmacy, Regulatory Affairs
• 12+ years in pharma/biotech Regulatory Affairs with Advertising/Promotion focus including leadership responsibility
• Proven expertise in FDA-regulated promotional compliance, COP/OPDP, and PI/label negotiations
• Comprehensive knowledge of FDCA, OPDP, FDAMA, PDMA, PhRMA Code, scientific exchange, misbranding, and fair balance
• Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory Affairs (preferred)
• RA Certification (RAC)
• Knowledge of global promotional regulations would be a plus

Benefits:

• Competitive rates for Health, Dental, and reputed company Insurance
• 4 weeks of vacation granted up reputed company each year and prorated for first and last year of employment
• 12 company paid holidays
• 7 days of sick time
• 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars
• 100% employer-paid short- and long-Term disability coverage
• 401(k) with immediate eligibility and company match
• Partially paid parental leave for eligible employees
• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance

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