Director, Global Labeling Strategy Lead

SGS_JOB_1016

Scientific
 Massachusetts
Global Labeling; Strategic Leadership; Cross-Functional Collaboration; Labeling Documents Authoring
Submission
and Labeling Negotiations

Contract - 6 Months+ (Potential Extension)

Accountable for developing and implementing labeling content and strategy for multiple drug development products, including TLPs, CCDS, USPI, and EU SmPC. Manages Labeling Cross-Functional Teams, fostering collaboration and aligning labeling strategy and content. Interfaces with Senior Management (GLOC) to secure labeling approval, ensuring alignment and preparation of GLOC Chair(s) and members. Works closely with the Head of Global Regulatory Affairs Marketed Products and Labeling.

Job Responsibilities:

  • Independently authors/manages communications for significant labeling and CCDS changes for assigned products. 
  • Utilizes project management skills to coordinate global labeling efforts, ensuring timely label creation, Health Authority submissions, and leading label negotiations. 
  • Interprets regulations and ensures labeling compliance with regulatory requirements. 
  • Manages local labeling exceptions, supports Local Affiliates, and aligns local labeling with CCDS. 
  • Escalates issues to Global Labeling management and GRL, proposing risk mitigation strategies. 
  • Builds strong cross-functional relationships (clinical, safety, medical, commercial) to align labeling strategy and content. 
  • Conducts precedent searches, analyzes competitor labeling, and tracks labeling trends to develop competitive and compliant labeling strategies. 
  • Represents Global Labeling at GRT, collaborates with Labeling Operations, and supports Health Authority inspections. 
  • Drives departmental and cross-functional initiatives to enhance labeling processes and outcomes.
  • Vendor Management
  • Continuous Improvement

Skills:

  • 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.
  • In-depth expertise of US and EU product labeling requirements, regulations, and guidelines.
  • Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape.
  • Understanding of other relevant regional regulatory nuances and requirements.
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development.
  • Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions.
  • Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.
  • Ability to independently develop target labeling profile (TLP).
  • Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.
  • Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.

Education/Experience:

  • BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.

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