Global Labeling Strategy Lead — Associate Director

Millipore Corporation; Billerica (MA); Hybrid; USD 134,000 - 202,000; Full time

Job summary

Millipore Corporation in Billerica, MA, is seeking an Associate Director of Global Labeling / Labeling Product Lead to harmonize labeling worldwide. You will lead CCDS creation, manage US/EU PIs, and support regulatory affairs with cross-functional teams to ensure global labeling compliance.

This hybrid role requires leading labeling teams, presenting to senior management, and developing labeling content for development products, with a focus on accuracy and regulatory alignment.

Qualifications

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

Responsibilities

• Create and maintain global CCDS in collaboration with product teams to serve as the basis for worldwide harmonized labeling.
• 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.

Skills

Labeling experience

Regulatory affairs knowledge

Cross-functional collaboration

Communication skills

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

Millipore Corporation in Billerica, MA, is seeking an Associate Director of Global Labeling / Labeling Product Lead to harmonize labeling worldwide. You will lead CCDS creation, manage US/EU PIs, and support regulatory affairs with cross-functional teams to ensure global labeling compliance.

This hybrid role requires leading labeling teams, presenting to senior management, and developing labeling content for development products, with a focus on accuracy and regulatory alignment.