Director, Global Labeling - Regulatory Affairs

About SpringWorks Therapeutics SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors. We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1‑PN). At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for. Your Role The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives. Location Classification – Hybrid This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. Key Accountabilities Lead the development, review, approval, and implementation process for CCDSs, USPIs, EU SmPCs and labeling documents with cross-functional labeling teams. Prepare for senior management (LDB) review and approval. Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients. Provide tactical guidance to labeling teams regarding the labeling process, and regulatory requirements including application to product labeling content. Disseminate labeling for implementation in the US/EU and support country regulatory affairs in implementation changes locally. Support products in development by providing input into investigational brochures, development safety update reports and integrated evidence planning. In some cases, develop regulatory labeling strategy and content for products in development (i.e., target product label) with subject matter experts. Maintain expertise regarding key labeling requirements worldwide and stay updated with FDA/EMA labeling guidelines and regulations. Participate in labeling negotiations with agencies resulting in product approvals or labeling updates. In collaboration with department head, develop and periodically review labeling policies and standards. Provide guidance, and in some cases, drive process improvement initiatives. Support audits and CAPA resolutions. Represent labeling on cross-functional leadership programs and advisory boards. Minimum Qualifications 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 Preferred Qualifications Advanced degree (PhD, MD, MS, PharmD, MBA) Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS) Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance Excellent written and oral communication skills Knowledge and application of labeling requirements in global countries including Japan and China Knowledge of global drug‑development and life‑cycle management regulations Compensation & Benefits The expected salary range for this position is $182,100 - 273,100. 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. We offer best‑in‑class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. For more information, see our benefits page. EEO Statement SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks’ Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities. This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment. #J-18808-Ljbffr