Regulatory Affairs Labeling Director

November 1

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SpringWorks Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• About SpringWorks Therapeutics: • 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. • SpringWorks has a diversified targeted oncology pipeline. • The Regulatory Affairs Labeling Director will serve as an expert resource for regulatory labeling and lead the development and implementation of labeling for SpringWorks products. • Maintain awareness of FDA, EMA, and international health authority regulations to ensure labeling is compliant. • 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. • Conduct research on competitor and other relevant labeling precedents. • Develop project timelines and manage labeling projects from initiation to completion. • Lead Core Label Working group meetings and provide strategic regulatory guidance. • Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents. • Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling. • Help develop, review, and approve global package artwork. • Perform other duties and responsibilities as assigned.

Requirements

• 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. • 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

Benefits

• Best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. • Review additional information here Benefits.