Facet Life Sciences is a regulatory affairs and software company that has been transforming the way small life sciences organizations get their products to and through FDA. We are committed to consistently delivering the highest quality strategic regulatory affairs and development support using enabling software that has become synonymous with the Facet name. We value practical and honest approaches and view business challenges as catalysts that spark innovation. Our customers’ goals are our priorities and fuel our efforts to create novel solutions that streamline R&D practices.
The Regulatory Affairs Director (called a Product Development Champion [PDC] at Facet) is a remote (work from home) position focused on helping emerging companies advance their drugs, biologics, cellular, protein, gene therapies, vaccines, combination products, and medical devices through any or all stages of regulated development. This involves helping some companies determine what is needed to get their product from the bench into humans. For others, the path to success involves developing and executing an aggressive clinical and regulatory plan to achieve registration with FDA under tight budget constraints.
At Facet, the PDC:
● Develops and leads innovative US regulatory strategies and contingency plans for the development and registration of drugs, biologics, vaccines, medical devices, cellular, protein, gene therapy, and combination products.
● Serves as a dynamic, engaged, and strategic liaison between Facet clients and FDA (US Agent)
● Champions FDA meeting activities, including preparation of meeting materials, meeting preparation, and meeting attendance
● Actively participates in the preparation of regulatory submission content. Works with cross-functional teams and partner organizations to define contributions to submissions
● Serves as the clinical and/or CMC regulatory content expert on project teams and within Facet
● Authors and/or reviews regulatory documents for regulatory submission.
● Maintains knowledge of the global competitive landscape, regulatory environment, regulations, and guidance
● Actively participates in service to the industry (e.g., industry memberships, conference presentations, publications)
The successful candidate will:
● Be excited by and capable of “taking center stage” and lead development programs, champion regulatory strategies, and effectively work with a variety of personality types
● Enthusiastically develop regulatory and scientific strategies based on client input (stated goals, corporate objectives, and risk tolerance), experience with the regulatory, medical and commercial environment, and through strong teamwork with Facet colleagues and partners. This includes
o the courage to suggest and ability to defend innovative scientifically grounded approaches to regulated development
o a willingness to “bird-dog” information and provide actionable regulatory guidance in the face of uncertainty using assumption setting and estimation of success probabilities
● Bring strong scientific and technical writing skills, experience authoring regulatory submission documents, and an ability to convey complex concepts succinctly
● Enjoy working closely and collaboratively with a team of experts to bring the best possible guidance and support to Facet’s clients
● Continue to grow professionally through planned training and service activities related to regulatory affairs and/or scientific discipline(s)
Direct experience working on regulatory submissions to FDA is required.
Facet is a highly ethical company that strives to do right by our customers and our colleagues all the time. We firmly believe in healthy work/family balance and rewarding our people for all the great work that they do. Benefits include, but are not limited to:
● Fully remote (work from home)
● Flexible working hours
● Competitive salary and PTO package
● “Rising Tides” bonus if the company meets its corporate objectives
● Personal merit-based bonuses
● Medical and dental insurance
● Professional insurance
● 401K program
● Support for professional development
● Annual face-to-face all-hands event at a fun location
Valid through: 6/3/2021