Tricida, Inc. is located in South San Francisco CA and we are looking for an on-site Manager, Regulatory Affairs. The qualified candidate in this position will actively contribute to the development of Tricida’s investigational product by serving as the regulatory lead on a global clinical trial and supporting future marketing application submissions. Your responsibilities will include coordinating clinical and nonclinical regulatory submissions, such as IND/CTA and NDA/MAA submissions, supporting new and ongoing clinical trials, and providing guidance to project teams regarding regulatory submission strategy and requirements that are consistent with current regulations, guidelines and industry standards.
Represent Regulatory on the clinical project team for a global clinical trial.
Lead the preparation and/or review of clinical and nonclinical filings in the US and ex-US, including IND amendments, CTAs, and annual or other periodic reports, and future NDA/MAA submissions for Tricida’s lead polymer product.
Perform regulatory review of clinical and nonclinical study documents (e.g., protocols, ICFs, IB, safety reports/narratives, and study labels) for adherence to regulations, guidelines, commitments and strategies.
Manage regulatory timelines for assigned projects and ensure consistency with project timelines.
Coordinate written responses to information requests from regulatory authorities.
Proactively mitigate potential risks and partner effectively and positively to solve issues.
Support preparation for, and participate in, GCP inspection activities and other regulatory compliance-related activities as needed.
Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect Tricida products and advise project teams accordingly.
Conduct regulatory research on competitor activity and positioning.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures and review other company procedures, as needed.
5+ years experience in the pharmaceutical/biotechnology industry including at least 3 years in Regulatory Affairs.
Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions for drug/biologic products, preferably in late stage development.
Experience with submitting documents to regulatory authorities in eCTD format.
Experience with NDA submission(s) a plus.
Strong knowledge of FDA/ICH regulations and guidelines, particularly GCPs.
Strategic and flexible thinker, planner and implementer.
Excellent organizational, communications and presentation skills.
Ability to prioritize and manage multiple projects and tasks with flexibility in a fast-paced biopharmaceutical company.
Experience working in cross-functional, global, virtual
Excellent interpersonal and organizational skills, with the ability to build relationships at all levels of the organization, including external
Ability to travel up to 5%, domestic
Internal Number: 310.113
About Tricida, Inc
Tricida, Inc., is a late-stage pharmaceutical company focused on the development and commercialization of its lead product candidate, TRC101, a non-absorbed, orally-administered polymer drug designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. Metabolic acidosis has been associated with increased muscle wasting, loss of bone density and increased mortality.
Tricida has successfully completed a pivotal Phase 3, double-blind, placebo-controlled trial of TRC101 in CKD patients with metabolic acidosis (TRCA-301) that evaluated the safety, tolerability and efficacy of TRC101 in subjects with CKD and metabolic acidosis. The results of the TRCA301 trial along with results from a successful double-blind, randomized, placebo-controlled Phase 1/2 trial and an ongoing safety extension trial, TRCA-301E, are intended to serve as the basis for the submission of a U.S. New Drug Application (NDA) for TRC101 under the Accelerated Approval Program of the U.S. Food and Drug Administration (FDA).
Tricida was founded in August of 2013 by a... seasoned management team that has extensive experience in the development and commercialization of therapeutics, with substantial expertise in developing polymers for the treatment of kidney-related diseases.