Regulatory Affairs Labeling Director

About the Role:

The Regulatory Affairs Labeling Director will serve as an expert resource for regulatory labeling and will lead the successful development and implementation of labeling for SpringWorks products. This individual will maintain a continued awareness and understanding of FDA, EMA, and international health authority regulations to ensure labeling is compliant. 

Location Classification – Remote:

Officially classified as working full-time from employee’s home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs

Key Responsibilities:

• Create and maintain labeling content for marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork 
• 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  
• Develop project timelines and manage labeling projects from initiation to completion 
• Lead Core Label Working group meetings and provide strategic regulatory guidance, as appropriate 
• Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork) 
• Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling 
• Help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and external partners 
• Perform other duties and responsibilities as assigned

Qualifications:  

• Education: 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.
• Experience representing Regulatory Affairs Labeling on cross functional teams
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others
• Experience in interpreting regulations, guidelines, and policy statements relevant to labeling
• Comprehensive knowledge of labeling regulations in the U.S. and Europe
• Model SpringWorks Leadership Principles to drive a collaborative function that embraces innovation and drives superior employee experience through growth management.
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.
• This position must be able to work East Coast hours. #LI-Remote

Compensation:

The expected salary range for this position is $167,375.00 - $220,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.