Regulatory Labeling Associate Director

Vertex Inc.•Boston, MA

2d•$161,600 - $242,400•Remote

About The Position

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.

Requirements

Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA.
Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory global and/or regional labeling, and to use this information to support regulatory responsibilities that align with business objectives.
Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools, and maintains a continuous learning mindset to strengthen regulatory strategy, decision-making, and operational efficiency.
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 in a systematic and efficient manner.
Strong understanding of the compliance and operational requirements for labeling
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.

Responsibilities

Ensures compliance with labeling governance requirements and associated business processes.
Leads label working groups and representing labeling at senior labeling governance meetings.
Develops and maintains global product labeling for one or more products. This includes the company core datasheets and labeling for the major markets, or multiple rest of world market-specific labels and associated packaging components and may include target label profiles.
Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling requirements for quality, preclinical and clinical data and oversight of health authority interactions regarding all aspects of labeling across a one or more products at the global level or across several ROW markets for a given therapeutic area, including responses to questions, negotiations, and inspections.