Proclinical Staffing ยท 4 weeks ago
Executive Director, Regulatory Affairs, Advertising & Promotion
New Jersey, United States
Full-time
Hybrid
Director/Executive
15+ years expProclinical is seeking an Executive Director, Regulatory Affairs, Advertising & Promotion for a successful global pharmaceutical company based in New Jersey. In this role, you will manage the review and approval of advertising and promotional labeling pieces for prescription, over the counter, and cosmetics products, ensuring compliance with regulatory requirements.
Staffing & Recruiting
Hiring Manager
Phu Huynh
Responsibilities
Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products
This position may require reviewing promotional materials if the company requires it and escalations
This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives
Provide guidance on proposed claims for products in development and development of ISI and brief summaries
Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters
Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Canada Pharmaceutical Advertising Advisory Board (PAAB) and other regulatory considerations that may impact business
Develop or revise procedures needed
Review packages for regulatory advice, resolution of FDA and Canadian action letters and leads the company in discussions with the FDA OPDP and Canada PAAB
Qualification
Required
Bachelor's degree in science or health related discipline
Minimum 15 years of regulatory affairs product advertising and promotion and people management experience
People leadership experience
Preferred
Advanced degree PhD, MD, MS, PharmD
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
51-200 employees
H1B Sponsorship
Proclinical Staffing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase