Senior Director, Regulatory Affairs
San Diego, CA
Senior Director, Regulatory Affairs
General Job Description:
COMPANY SUMMARY: 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 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 certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva® launch in 2016 also marked Intercept’s successful transition from a development-stage company to a fully integrated commercial organization with continued growth. In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (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. 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 submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. 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 Regulatory Affairs will play a pivotal role in preparing the company for the successful anticipated launch of OCA’s second indication. POSITION SUMMARY: 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.
The successful candidate must be able to perform each of the following 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, NOA, 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
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities
Make Intercept a truly desired place to work
Bachelor's degree in Biology, Chemistry or life sciences, advanced degree preferred
10+ years of industry knowledge experience (pharma, biotech, CRO). Experience across different sized organizations (such as both biotechnology and pharmaceutical companies) is preferable
10+ years of regulatory experience.
REQUIRED KNOWLEDGE AND ABILITIES:
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.
Strong verbal and written communications skills
Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
Understanding the legal and compliance environment
Ability to have fun!
Application Information & Contact (How to Apply)
Please apply through the Intercept Job Board found here.