Director, Global Labeling - Regulatory Affairs

Work Location:

Billerica, Massachusetts

Shift: No

Department: HC-RD-RRF Regulatory Affairs for Advertising Promotion

Role-Level: 4

Spring Works 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 the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN).

At Spring Works, 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.

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.

This role will be required to work onsite 3 days a week (Tuesday
- Thursday) or more depending on business needs. #LI-Hybrid

• 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.

• 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

• 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

Change Steward
- Recognize that change is essential; set goals that align to the Company's strategy and create…