Regulatory Strategy Associate Director

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 168,000 - 252,000; Full time

Benefits offered by this job

Generous paid time off

Educational assistance programs

401(k) matching

Job summary

Vertex Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed products. The ideal candidate will have a strong understanding of regulatory affairs frameworks and a minimum of 8 years experience in the biotech or pharmaceutical industry.

This role includes leading regulatory communications, advising teams, and ensuring compliance of submissions. Vertex offers a hybrid work model and a comprehensive benefits package.

Qualifications

• Typically requires 8 years of relevant pharmaceutical or biotech industry experience within regulatory affairs.
• Prior experience with major health authority submissions and interactions.

Responsibilities

• Oversee development of regulatory strategy for development programs.
• Lead communications with health authorities.
• Advise teams on regulatory requirements and approval pathways.

Skills

Knowledge of regulatory affairs frameworks

Drug development understanding

Problem-solving skills

Strong communication skills

Team leadership ability

Education

Bachelor's degree in biology, chemistry, or related discipline

Job description

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

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.

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 [e-mail]