Director, Global Labeling - Regulatory Affairs

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

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. #LI-Hybrid

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.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.