About PendulumPendulum® is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics™ (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration.Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them.We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual's transparency and strong communication to enable the most effective and efficient path to team success.If you're interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading!Position Summary:We are seeking a regulatory affairs specialist to assist with ensuring regulatory compliance. The Regulatory Affairs team is highly cross-functional and work will center on collaborating with internal scientific, business and operational teams to address compliance needs of our novel probiotics and dietary supplements.The regulatory specialist will review and substantiate product and marketing claims for regulatory compliance, assist with regulatory applications and filings, and maintain regulatory data and documents. The successful candidate will have the motivation and flexibility to work in a fast paced, start up environment.What You'll Do:Research and read scientific literature and data to substantiate desired product claims, ancillary claims, and science statements.Review and provide regulatory guidance on marketing and advertising materials, including website, testimonials, videos, newsletters, and slide decks.Provide regulatory support for Customer Service questions.Review and provide regulatory support for Customer (Shopify) reviews.Help prepare submissions to the US Food and Drug Administration (FDA) and other global regulatory agencies.Organize, update and maintain internal regulatory database and folders to provide a centralized, accurate documentation resource.Knowledge Requirements:B.A./B.S. or M.S. in Biology/Biological Sciences, Food Science or related discipline0-3 years industry experience in regulatory affairs, experience working with food/dietary supplements is preferred. Experience with microorganisms is a plus. Strong scientific reading comprehension and writing ability. Strong communication skills Strong organizational and time management skills. Keen eye for detail.Proficient in MS Office (Word, Excel, Powerpoint) and/or Google SuiteAbility to work under aggressive project timelinesHybrid work environment – onsite minimum 2 days a weekSalary & Benefits$76,500 - $102,600Medical, Dental, and VisionCommuter BenefitsLife & STD InsuranceCompany match on 401 (k)Flexible Time Off (FTO)EquityPendulum Therapeutics, Inc. is committed to creating a diverse environment and is proud to be an equalopportunity employer. All qualified applicants will receive consideration for employment without regard torace, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics,disability, age, or veteran status. We welcome all to apply.
