Somerset County, New Jersey
Kieran O'Connor, J.D.
8 months ago
Director/Senior Director, Regulatory Affairs (Ad/Promo)
Location: Somerset County, NJ
Type: Permanent Position
My Client is a rapidly growing Biotech in Central Jersey. As a Director/Senior Director representing Regulatory on the US Ad/Promo Regulatory Review team, you will be entrusted to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. In this role, you will contribute the company’s progress by providing regulatory strategic oversight for complex products or therapeutic area products to help ensure regulatory compliance of promotional materials generated for assigned products.
- Serves as a primary regulatory advertising and promotion reviewer on cross-functional Product Review Committee (PRC) teams for assigned products and provide feedback on
- Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities
- All related internal sales training materials.
- Corporate materials
- All marketing, advertising and promotional materials
- Materials developed by Medical Affairs
- External disease state communications
- Ensures changes to the US labeling are appropriately implemented into product promotional materials
- Develops solutions to complex US promotional issues by utilizing scientific, regulatory and therapeutic area knowledge to support business objectives and initiatives while effectively managing business risks
- Bachelor’s degree; advanced scientific related degree a plus
- 5+ years of experience in pharmaceutical industry.
- 2+ years of experience in regulatory review of ad/promo materials.
- Background in prescription drugs and/or biologics.
- Experience in oncology/rare diseases drug development a plus
- Demonstrate excellent communication skills.
- Excellent organization, detail oriented and multi-tasking skills.
I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Kieran O’Connor at 646-349-5043 or at K.Oconnor@hamlynwilliams.com