Regulatory Strategy Associate Director

Job Title: Regulatory Strategy Associate Director

Job Location: 5000 - Vertex US - Fan Pier, United States of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Description General Summary: The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development. 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 Advises teams on regulatory requirements for development and approval pathways, including potential for expedited pathways Leads and oversees the process for preparation, submission, and approval of regulatory applications Provides strategic and technical regulatory input for key product development or registration documents Ensures compliance of regulatory submissions with current regulations and guidance Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s) Acts 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 Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment Strong problem-solving skills 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. Strong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view Ability to effectively lead and work within a team environment Prior experience with major health authority submissions and health authority interactions is required. 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 #LI-Hybrid 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: 1. Hybrid: work remotely up to two days per week; or select 2. 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. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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