Greater Boston Area
9 months ago
U.S. Regulatory Lead: Advertising and Promotion
This role will be responsible for the review and assessment of proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements. You will work collaboratively with cross functional teams in regulatory affairs, commercial, legal, and compliance as well as maintain favorable relations with the FDA. This is also an opportunity to directly supervise individuals.
-Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
-Ideal candidate has a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 2 years’ experience specific to Advertising and Promotion. Candidates with experience in related fields may also be considered.
-Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
-Expert understanding of FDA regulations regarding advertising and promotion\
Our client is seeking exceptional talent in this arena and would like to fill this role as soon as possible, so please apply immediately.