Senior Manager, Global Labeling Operations

Key Responsibilities

• Support the development, maintenance, and review of documentation related to global labeling processes, including policies, standard operating procedures, work instructions, and supporting documents.
• Cook up and track labeling document updates, internal milestones, and stakeholder inputs to support timely execution and alignment across global and regional teams.
• Develop and maintain global labeling project plans, submission timelines, and health authority interaction tracking to ensure commitments and deliverables are visible, current, and effectively managed.
• Establish and oversee a comprehensive global labeling commitment tracker to promote timely follow-through, accountability, and alignment with regulatory expectations and required timelines.
• Monitor implementation of new and updated labeling in markets, manage exceptions and deviations, and track compliance metrics to support on-time submissions and implementation.
• Partner with cross-functional RQS stakeholders on quality documentation, filing timelines, safety-related commitments, and related operational deliverables.
• Identify and implement process improvements, digital solutions, and new technologies that simplify work, improve labeling quality, and increase operational efficiency.

Who You Are

• Minimum Qualifications: Bachelor’s degree in a science or health-related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred. Minimum of 5-years of pharmaceutical industry or related experience.
• Operational excellence and continuous improvement mindset; experience contributing to cross-functional initiatives, process improvement efforts, or operational excellence projects.
• Demonstrated ability to manage multiple priorities, meet deadlines, work independently, and maintain accurate, high-quality documentation.
• Digital fluency and willingness to adopt innovative ways of working.
• Knowledge of global labeling regulations, regulatory submission processes, and health authority expectations.
• Experience supporting labeling governance, commitment tracking, market implementation, or compliance monitoring activities.
• Familiarity with change management, continuous improvement, process mapping, metrics, or operational performance tracking.
• Experience working in matrixed, global organizations and partnering with regulatory, safety, quality, medical, commercial, and regional stakeholders.

Location

Billerica, MA, USA; Onsite (3x week)

Travel

International and Domestic:

Pay Range

$127,900.00 - $191,800.00

What we offer

• We are curious minds that come 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!