Regulatory Labeling Associate Director

Job Description

General Summary:

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.

Key Duties and 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.

Knowledge and Skills:

• 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

Education and Experience:

• 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.

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Pay Range:
$161,600 - $242,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:
Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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