Labeling Compliance Manager

3 weeks ago


Boston, Massachusetts, United States SpringWorks Therapeutics Full time
Job Overview

We are seeking a highly skilled and experienced Regulatory Affairs Labeling Director to join our team at SpringWorks Therapeutics.

This is a remote opportunity that requires the ability to work independently and collaboratively with cross-functional teams. The successful candidate will be responsible for leading the development and implementation of labeling for our products, ensuring compliance with FDA, EMA, and international health authority regulations.

The estimated salary range for this position is $167,375.00 - $220,000.00 per year, depending on experience and qualifications.

About SpringWorks Therapeutics

SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on developing life-changing medicines for people with severe rare diseases and cancer.

We have a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers.

Key Responsibilities
  • Create and maintain labeling content for marketed product(s) and development products in US and international regions.
  • Liaise with external partners or distributors in international markets as applicable.
  • Conduct research on competitor and other relevant labeling precedents to support high-quality, commercially viable labels.
Requirements
  • Bachelor's Degree in life sciences or related science degree; advanced degree preferred.
  • 9+ years of related experience within regulatory affairs with a bachelor's degree; or 7+ years of related experience within regulatory affairs with a master's degree; or a PhD with 4+ years' of related experience within regulatory affairs with; or equivalent experience.
  • Oncology, rare disease, and/or other relevant therapeutic area experience is desirable.


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