Regulatory Strategy Manager

Job Description

General Summary:

The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of US regional or global regulatory strategies for development and commercialization of program(s) within the portfolio. This role requires a good understanding of regulatory affairs frameworks, the drug development process, and related concepts.

Key Duties and Responsibilities:

• Contributes to the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
• Develops proficiency in regional and global regulatory skills
• Supports global regulatory strategy under guidance of the Global Regulatory Lead
• Responsible for regulatory communications with local health authority; under supervision, may lead regulatory interactions with the health authority
• Identifies regulatory requirements for development and approval pathways for assigned region
• Under supervision, manages the process for preparation, submission, and approval of regulatory applications within assigned region
• Provides technical regulatory input for key product development or registration documents
• Works to ensure compliance of regulatory submissions with current regulations and guidance
• Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in assigned region

Knowledge and Skills:

• Good knowledge of regional regulatory affairs frameworks
• Understanding of requirements and processes to maintain a product on the market; reporting and surveillance
• Understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
• Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines
• Strong problem-solving skills
• Strong written and verbal communication skills to exchange complex information with others in complex situations
• Ability to work effectively within a team environment
• Ability to plan, prioritize, and contribute to work and projects in a systematic and efficient manner

Education and Experience:

• Bachelor's degree in Biology, Chemistry, or other related discipline
• Typically requires 4 years of relevant pharmaceutical or biotech industry experience or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

Flex Designation:

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