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 marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in early 2022.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Manager or Senior Manager of Regulatory Affairs. This position provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, CTA approval, etc. This position also provides support to Global Regulatory Leaders (GRLs) with activities related to global regulatory strategy.
The successful candidate must be able to perform each of the following satisfactorily:
- Assist in the development and implementation of national and international regulatory strategies
- Regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
- Responsible for partnering with cross-functional teams to meet submission deadlines
- Help coordinate international CTA submissions while managing and partnering with CROs
- Represent Regulatory Affairs on the study teams, and assess regulatory pathways for submissions to the FDA and other regulatory agencies
- Provide support to GRL with development of Global Regulatory Plans and Global Regulatory Submission Plans
- Review regulatory documents such as pediatric plans, briefing books, meeting requests, DSURs, etc.
- Assist with submissions, such as INDs, NDAs, MAAs, and supplements to support project development plans and timelines
- Identify and communicate potential regulatory risks and mitigations to the study team
- Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
- Provide mentorship and support to colleagues to support their activities and in helping with the production of appropriate reports and documents
- Assumes other relevant assignments as assigned by VP or other RA managers.
- Assist Regulatory department in the update and creation of internal policies and procedures
- Work is performed under limited direction and supervision from a Senior Regulatory Affairs professional
- 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
Experience and Skills
- Bachelor's degree required; MS or PhD preferred
- Minimum 4 years of industry experience supporting regulatory affairs with a BS degree or equivalent regulatory experience with MS or PhD (Manager); Minimum 6 years of industry experience supporting regulatory affairs with a BS degree or equivalent regulatory experience with MS or PhD (Senior Manager)
- Understanding of/experience in global CTA submissions
- Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
REQUIRED KNOWLEDGE AND ABILITIES:
- Detail-oriented and ability to work across functions
- 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: come together, be yourself, own the solution, embrace the challenge, keep exploring
- Ability to have fun and thrive in a growing, diverse, and inclusive work environment