[Hiring] Regulatory Labeling Associate Director @Vertex Inc.

Role Description

The Regulatory Labeling Associate Director will be responsible for strategic labeling and for executing on one or more products either at the global label-level (CCDS, USPI, EuSmPC) or in multiple ROW countries/regions for a given therapeutic area. This role may be accountable/responsible for specific business processes and may also be responsible for the development and management of a TLP with some guidance.

• Ensures compliance with labeling governance requirements and associated business processes.
• Leads label working groups and represents labeling at senior labeling governance meetings.
• Develops and maintains global product labeling for one or more products, including:
  • Company core datasheets
  • Labeling for major markets
  • Multiple rest of world market-specific labels and associated packaging components
  • Target label profiles
• Contributes to labeling strategy with a proficient ability to advise stakeholders on regulatory labeling requirements for:
  • Quality
  • Preclinical and clinical data
  • Oversight of health authority interactions regarding all aspects of labeling

Qualifications

• Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and global regulatory authorities (FDA, EMA, etc.).
• Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory global and/or regional labeling.
• Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools.
• Proactively remains up to date on advances with technology, AI, automation, competitive intelligence, and changes in the regulatory environment.
• Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory global and/or regional labeling.
• Strong understanding of the compliance and operational requirements for labeling.

Requirements

• Bachelor’s degree, with a preference in a life sciences field.
• Typically requires 8 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) and more.

Flex Designation

Remote-Eligible

• Remote: work remotely five days per week and come into the office on occasion.
• Hybrid: work remotely up to two days per week.
• On-Site: work five days per week on-site with ad hoc flexibility.