Regulatory Strategy Manager

Job Description

General Summary:

The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in the US, Europe, or other international markets, and understanding of drug development and related concepts.

Key Duties and Responsibilities:

Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team

Contributes to and may lead global regulatory strategy development for certain programs

Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority

Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways

Manages the process for preparation, submission, and approval of regulatory applications within assigned region

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 in assigned region

Knowledge and Skills:

In-depth knowledge of global and regional regulatory affairs frameworks

Good understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology

Good understanding of requirements and processes to maintain a product on the market; 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

Strong written and verbal communication skills to explain difficult information and build alignment

Ability to work effectively within a team environment

Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner

Education and Experience:

Bachelor's degree in Biology, Chemistry, or other related discipline

Typically requires 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

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 [email protected]