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 Form 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/social 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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