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About the Role
The Regulatory Strategy Senior Manager will contribute regional or global regulatory strategy expertise for development programs or marketed products, serving as a regional or global regulatory lead for products within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks and drug development concepts.
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
Requirements
- 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
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
Location
- On-Site
- Remote
Work Type
- Hybrid
- On-Site
Experience Level
- 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs
Education Level
- Bachelor's degree in Biology, Chemistry, or other related discipline
About the Company
- Vertex is a global biotechnology company that invests in scientific innovation.
- 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.
Equal Opportunity
- 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