Regulatory Strategy Associate Director

General Summary

The Regulatory Strategy Associate Director will oversee the development of regional or global regulatory strategy for development programs or marketed products. This role serves as a global or regional regulatory lead for development and/or commercial product(s) within the Vertex portfolio and contributes to the global regulatory strategy for the assigned program(s).

Key Duties And Responsibilities

• Lead the development and implementation of global regulatory strategy for assigned projects in development through commercial stages.
• Contributes to and may lead the development and implementation of regional regulatory strategy to inform the global strategy for certain projects.
• Leads regulatory communications and interactions with health authorities.
• Advise teams on regulatory requirements for development and approval pathways, including potential for expedited pathways.
• Lead and oversee the process for preparation, submission, and approval of regulatory applications.
• Provide strategic and technical regulatory input for key product development or registration documents.
• Ensure compliance of regulatory submissions with current regulations and guidance.
• Review and evaluate regulatory intelligence and guidance information to continuously inform regulatory strategy.
• Advise cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s).
• Act as an advisor and coach to mentor members of the team.

Knowledge And Skills

• Specialized knowledge of global and regional regulatory affairs frameworks and guidelines.
• Understanding of requirements and processes to maintain a product on the market; reporting and surveillance.
• Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
• Comprehensive understanding of requirements and processes to maintain a product on the market, product labeling, reporting, and surveillance.
• Able to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
• Strong problem-solving skills.
• Proactively remains up to date on advances with technology, AI, automation, competitive intelligence and changes in the regulatory environment.
• Strong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view.
• 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.

Education And Experience

• Bachelor's degree in biology, Chemistry, or other related discipline.
• Typically requires 8 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience.

Pay Range

$168,000 - $252,000

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 Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select 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.