Senior Manager, Regulatory Strategy

Senior Manager, Regulatory Strategy

Job DescriptionGeneral 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.Company InformationVertex 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.

#J-18808-Ljbffr