Director, Regulatory Affairs for Advertising Promotion (AdPromo)

April 5

SpringWorks Therapeutics

WebsiteLinkedInAll Job Openings

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer$1. .$1

201 - 500

Description

• The Regulatory Affairs Advertising & Promotion Director is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner. • Review and approve promotional, corporate and other non-promotional materials for relevant products and associated therapeutic areas. • Represent the commercial regulatory perspective at regulatory project team meetings. • Provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications. • Serve as a liaison to the FDA’s Office of Prescription Drug Promotion for respective product(s) and ensure materials are submitted to FDA in a timely manner.

Requirements

• Bachelor’s Degree within related discipline. Advanced Degree preferred • 9 years regulatory affairs experience within pharmaceutical or biotechnology industry • 5 years’ experience in regulatory affairs Ad/Promo preferred • Oncology, rare disease, and/or other relevant therapeutic area experience is desirable • Direct experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred • Strong leadership and communication skills • Ability to work East Coast hours • Must be able to travel occasionally including overnight stays

Benefits

• Competitive compensation • Annual cash bonuses and equity grants • 401K matching • Fully covered medical, dental, and vision plans • Full week of holiday break at year end • Comprehensive benefits package for employees and their families