Work Location: Billerica, Massachusetts
Shift:
Department: HC-RD-RPO TA Oncology / ImmunoOncology
Recruiter: Sarah Ellis
This information is for internals only. Please do not share outside of the organization.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
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prequisites. For more information click here.
