Vertex is offering a two-year Biopharmaceutical Industry Fellowship in Global Regulatory Affairs at the corporate headquarters in Boston MA. The Pharm.D. fellow(s) will have an opportunity to gain specialized and in-depth training in three-distinct areas of Global Regulatory Affairs including Regulatory Strategy; Global Labeling; and Advertising and Promotion for a period of six-months. The remaining six-months of the program will be spent in the area of global regulatory affairs where the Pharm.D. fellow(s) can envision beginning their career journey.
The structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.
North America Regulatory Strategy Primary Objectives
Manages, develops, and implements regulatory strategy in support of Vertex products and development programs
Support the planning, preparation and execution of high-quality regulatory submissions (e.g. IND/IND amendment, NDA/sNDA, DSUR, PSUR, CTA, and NDS/sNDS, etc.)
Ensure compliance of regulatory strategies and submissions with current regulations and guidance including title 21 CFR, FDA and ICH guidelines
Work in cross-functional team including clinical, statistics, medical affairs, commercial, and nonclinical groups to help operationalize regulatory strategy
Serves as regulatory contact for Regulatory Health Authorities
Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents
Global Labeling Primary Objectives
Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL), or Instructions for Use (IFUs).
Support development of regulatory labeling strategy and lead team in negotiating and maintaining competitive labeling with Health Authorities globally
Author and maintain core labeling documents including the Target Labeling Profile (TLP)
Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy
Assist in preparation of responses to labeling-related queries from Health Authorities
Advertising and Promotions Primary Objectives
Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, PhRMA guidelines, company policies and established precedents and recommends revisions/actions that balance risks and opportunities.
Manage the review and approval of promotional and non-promotional materials in a cross-functional team that includes commercial, medical affairs, and legal
Responsible for timely and accurate review of all materials for submission to FDA, including Form FDA 2253
Serve as member of the promotional review committee to ensure regulatory compliance for all communications
Liaison with OPDP regarding advertising and promotion for assigned products