Key Duties and Responsibilities:
•Leads 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
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
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
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid- or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site work 5 days per week with ad hoc flexibility.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.