Associate Director, Global Labeling Strategy Lead

Biopharma Careers; Billerica (MA); Hybrid; USD 134,000 - 202,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

Biopharma Careers is seeking an Associate Director of Global Labeling / Labeling Product Lead (LPL) based in the Boston area. The role leads harmonized labeling across regions, creates and maintains CCDS, US/EU PIs, and global packaging text in alignment with regulatory standards.

You will support country regulatory affairs to ensure NPI consistency, serve as labeling subject matter expert on health authority inquiries, and mentor labeling teams while driving cross-functional initiatives.

Qualifications

• Bachelor’s degree in science or health-related discipline.
• 5+ years of pharma industry experience with 3+ years in Regulatory Affairs Labeling.
• Deep knowledge of labeling requirements in US/EU.

Responsibilities

• Create and maintain global CCDS and US/EU PIs, ensuring consistency with CCDS.
• Oversee and approve US/EU PIs to align with regulatory standards.
• Lead cross-functional labeling team; present proposals to senior management and obtain approvals.

Skills

5+ years pharma labeling experience

Cross-functional collaboration

Regulatory affairs coordination

Education

Bachelor’s degree in science or health-related discipline

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

Tools

MS Office (Word, Excel, PowerPoint, Project)

SharePoint

regulatory systems (EDMS)

Job description

Work Location: Billerica, Massachusetts

Department: HC-RD-RPO TA Oncology / ImmunoOncology

Your Role:

The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in close collaboration with cross-functional labeling product teams by leading the creation and maintenance of Company Core Data Sheets (CCDS), regional labeling documents including US/EU product information (PIs), and global packaging text in compliance with regulatory standards. The LPL supports country regulatory affairs (CRA) in creating national product information (NPI) ensuring consistency with the CCDS or a reference label. The LPL is the subject matter expert on labeling-related health authority queries and may also develop target product labeling content for development products.

Location:

This is a hybrid, 3x/week in office position based in Billerica, MA

Key Accountabilities:

• Create and maintain global CCDS in collaboration with product teams to serve as the basis for worldwide harmonized labeling. In some cases, maintain RSI to represent company position.
• Manage the creation and maintenance, review and approval of US and EU PIs ensuring consistency with the CCDS.
• Lead cross-functional labeling team, prepare for and present proposals to the Labeling Senior Management Board, and secure internal approval of labeling content.
• Oversee and support implementation of CCDS content into local PIs.
• Coordinate and respond to labeling inquiries from health authorities and participate in regulatory negotiations.
• Lead the development of target product labeling content for development products, as needed.
• Provide competitive labeling analyses and maintain up-to-date knowledge of local and regional labeling requirements.
• Develop/contribute to labeling-related process documents and guidelines, propose company comments on regulatory initiatives, and drive cross-functional labeling initiatives.
• Train product labeling teams on labeling processes, guide other labeling experts on life-cycle management, and cultivate relationships with regulatory professionals, associations, and authorities.

Minimum Qualifications

• Bachelor’s degree in science or health-related discipline
• 5+ years of relevant pharmaceutical industry experience with 3+ years of relevant Regulatory Affairs Labeling experience
• Deep knowledge and application of labeling requirements in the US/EU

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

Pay Range for this position: $134,200 - 202,200

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites.

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.