Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
About Pendulum
Pendulum® 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.
Pendulum Therapeutics, Inc. is committed to creating a diverse environment and is proud to be an equal
opportunity employer. All qualified applicants will receive consideration for employment without regard to
race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics,
disability, age, or veteran status. We welcome all to apply.
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