Intercept Pharmaceuticals Director, Regulatory Affairs in San Diego, California
At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases.
Intercept’s lead product, Obeticholic Acid (OCA), is a potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name “Ocaliva,” is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH – a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA’s second indication.
This position will oversee the development and implementation of sound regulatory strategies for multiple products including the preparation of submission-relevant documents relating to company’s development activities.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Develop and implement sound national and international regulatory strategies for multiple products.
Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
Collaborate with responsible departments and leads preparation, review, and collection of documentation for regulatory submissions.
Provide critical review of all documentation supporting regulatory applications.
Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
Work with peers to develop standard operating procedures and departmental guidelines.
Participate as a full member of the research and development team(s) for the company’s products.
Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
Review and approve protocols, reports, and documents used in regulatory submissions.
Mentor regulatory associates and managers.
Assume other relevant assignments as directed by supervisor
Bachelor’s degree in Biology or Chemistry, advanced degree preferred
10 years of industry knowledge experience (pharma, biotech, CRO).
5 years of regulatory experience.
REQUIRED KNOWLEDGE AND ABILITIES:
Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem solving capabilities.
Proven negotiation skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes.
Keyword: Director, Regulatory Affairs
From: Intercept Pharmaceuticals