Director, Global Labeling - Regulatory Affairs

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 182,100 - 273,100; Full time

Job summary

EMD Serono, Inc. is seeking a Director of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves overseeing the development and approval of labeling documents while ensuring compliance with global standards. Candidates should have over 8 years of pharmaceutical experience and a relevant Bachelor's or Advanced degree.

The position offers a hybrid work model, requiring onsite presence 3 days a week in Billerica, MA. A strong track record in regulatory affairs and excellent communication skills are essential for success in this role.

Qualifications

• 8+ years of relevant pharmaceutical industry experience.
• 5+ years of relevant Regulatory Affairs Labeling experience.
• Meticulous in reviewing regulatory documents.

Responsibilities

• Lead development and approval of regulatory labeling documents.
• Ensure labeling accuracy for healthcare professionals and patients.
• Maintain expertise on key labeling requirements worldwide.

Skills

Labeling requirements knowledge (US/EU)

Regulatory Affairs experience

Communication skills

Education

Bachelor’s degree in science or health-related discipline

Advanced degree (PhD, MD, MS, PharmD, MBA)

Tools

MS Office Suite

SharePoint

regulatory systems (e.g., EDMS)

Job description

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). We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock. Our approach values authenticity because a diversity of backgrounds, cultures, styles, and abilities helps us find the answers people with rare tumors need.

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 lead a therapeutic area (TA), overseeing Labeling Project Leads and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising & Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and drives 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.

SpringWorks Leadership Principles

• Change Steward – Recognize that change is essential; set goals that align to the Company’s strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever‑changing requirements.
• Excellence Driver – Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results.
• Growth Coach – Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers.
• Community Builder – Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment.

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.

What we offer

We are curious minds from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!