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Sr. Manager, Regulatory, Core Labeling Strategy

3 months ago

Boston, United States Attaineo Search, Inc. Full time
Job Description
Position Title: Senior Manager, Regulatory Core Labeling Strategy

Location: Boston, Massachusetts (Remote)

Overview:

We are seeking a dedicated and experienced Senior Manager for Core Labeling Strategy to lead and manage the labeling process and development for an assigned therapeutic area/portfolio. The individual will collaborate with internal teams, represent the organization in industry groups, and potentially manage direct reports within the labeling team, ensuring the company's compliance with relevant laws and regulations.

Key Responsibilities:

  • Lead the preparation, review, and approval of global and territorial labeling documentation to support regulatory filings for international regulatory agencies.
  • Develop labeling strategies in alignment with overall regulatory strategies, providing expertise on regulations, internal processes, and competitor profiles.
  • Establish partnerships with project leads and regulatory matrix, interfacing with senior management on business strategy and labeling content.
  • Collaborate with an aligned Regulatory Strategist and other stakeholder teams to lead all labeling aspects for the defined portfolio.
  • Evaluate the principles and data upon which labeling statements are based, ensuring their clinical relevance and regulatory acceptance.
  • Work with Global Product Safety and Risk Management to verify and agree on the content of PI texts, escalating issues to the Global Labeling Committee (GLC) when necessary.
  • Stay informed on competitor labels, external labeling trends, agency requirements, and negotiate the resolution of complex regulatory and scientific issues.
  • Represent the organization in various industry groups and at events sponsored by EMA or FDA.
  • Potentially manage, recruit, and motivate within the Labeling team, contributing to the leadership of the organization and driving effective governance through GLC processes.
Requirements
  • A minimum of a Bachelor's degree in science, Pharmacy, or a related field; a Master's Degree, PharmD, or PhD is preferred.
  • A combination of experience and/or education will be considered.
  • 7-10 years of experience with 5 or more years in Labeling and Labeling development.
  • Prior leadership experience or willingness to lead others.
  • In-depth knowledge of labeling, GLC requirements/processes, and EU/US regulations.
  • Highly developed interpersonal, presentation, and communication skills, with the ability to influence effectively in a matrixed, cross-functional team environment.
  • Ability to interpret comprehensive research documents, write scientific reports, and present to high levels of the organization.