Director, Regulatory Affairs - Advertising Promotion

September 7

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SpringWorks Therapeutics

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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

• Responsible for providing commercial regulatory strategy and leadership for US business • Review promotional materials for compliance with regulations and internal policies • Represent commercial regulatory perspective at MLR review committee • Advise stakeholders on regulatory impact of campaign concepts

Requirements

• Education: 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 • Experience in leading cross functional teams and advising Company stakeholders on changes in regulations • Proven ability to lead and influence data-driven strategy planning and implementation • Strong leadership and communication skills with success in influencing all levels cross-functionally • Strong interpersonal communication skills to collaborate effectively in a remote hybrid work environment • Ability to travel occasionally including overnight stay driven by business need

Benefits

• Competitive compensation • Annual cash bonuses • Equity grants • 401K matching • Fully covered medical, dental, and vision plans • Full week of holiday break at year end