Director, Global Labeling – Regulatory Affairs

SpringWorks Therapeutics

Director of Global Labeling providing strategic regulatory expertise and operational leadership at SpringWorks Therapeutics. Overseeing key labeling documents and managing cross functional teams in a hybrid environment.

Posted 6/10/2026full-timeBillerica • Massachusetts • 🇺🇸 United StatesLead💰 $182,100 - $273,100 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory labeling expertisecore data sheets (CCDS)regional labelingtarget product labelslabeling policiesprocess improvement initiatives

Soft Skills

operational leadershipguidanceteam management

Industry Keywords

pharmaceutical industryRegulatory Affairs Labelinglabeling requirementsUS labelingEU labeling

About the role

Key responsibilities & impact

Provide strategic regulatory labeling expertise and operational leadership to cross functional teams
Ensure the successful development of company core data sheets (CCDS), regional labeling, and target product labels
Assist the Head of Labeling and Advertising in preparing for and facilitating interactions with the Labeling Decision Board (LDB)
Develop labeling policies and standards, providing guidance and driving process improvement initiatives

Requirements

What you’ll need

Bachelor’s degree in science or health-related discipline
8+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
Deep knowledge and application of labeling requirements in the US/EU
Experience managing labeling personnel and/or teams

Benefits

Comp & perks

A discretionary annual bonus may be available based on individual and Company performance.
Best-in-class benefits for employees working with urgency on behalf of patients suffering from devastating diseases.