Senior Manager, Global Labeling

Eisai US; Nutley (NJ); On-site; USD 129,000 - 169,300; Full time

Benefits offered by this job

Annual Incentive Plan

Job summary

Eisai US seeks a Senior Manager, Global Labeling to lead development, review, approval, and maintenance of CCDS, CPI and CPI components for assigned products globally or regionally. The role represents the Global Labeling Group on project teams and serves as SME on regulatory labeling requirements.

You will coordinate cross-functional teams, guide CPI development on regulatory content and design, and ensure compliance with FDA/EU labeling while maintaining labeling histories and responding to

Qualifications

• Minimum BS degree or higher in life science.
• 8+ years of experience in drug development environment, with minimum 3-5 years of regulatory experience within the pharmaceutical industry.
• Experience in global and/or local regulatory labeling environments is preferred.
• Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and other markets labeling desirable.
• Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.

Responsibilities

• Coordinate and lead cross‑functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 30%
• Provide tactical and strategic guidance to CPI development teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis. 25%
• Manage direct reports. 10%
• Coordinate content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations. 10%
• Maintain labeling history documents and assist in responding to labeling‑related queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations on a global basis. 15%
• Participate or lead special assignments related to GRN, GL or other cross‑functional processes and/or activities. 10%

Job description

The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products and the Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. The Senior Manager, Global Labeling represents the Global Regulatory Network (GRN) Global Labeling Group on project teams and acts as a Subject Matter Expert (SME) on local, regional and multi‑country regulatory labeling requirements and participates in the sharing of intelligence. The Senior Manager, Global Labeling follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.

Essential Functions

• Coordinate and lead cross‑functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 30%
• Provide tactical and strategic guidance to CPI development teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis. 25%
• Manage direct reports. 10%
• Coordinate content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations. 10%
• Maintain labeling history documents and assist in responding to labeling‑related queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations on a global basis. 15%
• Participate or lead special assignments related to GRN, GL or other cross‑functional processes and/or activities. 10%

Requirements

• Minimum BS degree or higher in life science.
• 8+ years of experience in drug development environment, with minimum 3‑5 years of regulatory experience within the pharmaceutical industry.
• Experience in global and/or local regulatory labeling environments is preferred.
• Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and other markets labeling desirable.
• Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.

Eisai Salary Transparency Language

The annual base salary range for the Senior Manager, Global Labeling is from $129,000 to $169,300. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position; please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and, as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

E-Verify Participation: Eisai Inc. participates in E‑Verify. E‑Verify is an Internet‑based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.