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), which impacts 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.
The Associate Director, Regulatory Affairs, will provide regulatory support for pipeline and investigational product activities. This position may also oversee the execution and implementation of sound regulatory strategies for multiple products including the preparation of submission-relevant documents relating to company's development activities.
This position will provide regulatory support to cross-functional teams that may include clinical operations, clinical development, quality, new products and pharmacovigilance members based on project need.
Provide support to Global Regulatory Leaders with activities related to global regulatory strategy.
Provide regulatory guidance to other regulatory strategy team members related to global clinical study submissions and interactions with Health Agencies.
The successful candidate must be able to perform each of the following satisfactorily:
- Assist in overseeing the execution and implementation of national and international regulatory strategies.
- Manage regulatory review of study documents such as protocol, protocol amendment, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements.
- Manage effective collaborations with CROs and/or regulatory partners to plan and implement regulatory submissions worldwide that meet regulatory requirements.
- Assist in management of timelines for submissions and review for completeness, compliance and quality (both national and international programs
- Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory agencies.
- Represent Regulatory Affairs on the Study teams
- Provide support to GRL with development of Global Regulatory Plans, Global Regulatory Engagement Plan, Global Regulatory Submission Plan, or other regulatory documents such as Pediatric Plans, Briefing Books, etc. Assist GRL with implementation of regulatory strategy.
- Assist with submissions, such as IND, NDA, MAA, to support project development plans and timelines
- Initiate and support the development and revision of standard processes and procedures, helping improve quality and efficiency in RA department and across the organization
- Review, assimilate and summarize relevant ICH and HA guidances and regulations and provide training/recommendations to relevant ICPT personnel
- Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
- Provides 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.
- 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 in Biology, Chemistry or life sciences required. Advanced degree (MS, PhD) preferred.
- Requires a minimum of 8 years industry regulatory experience; 6 years with a MS or advanced degree.
- Solid understanding of/experience in quality systems and procedures.
- Solid understanding of quality compliance and the cross functional drug development processes (Clinical Operations, Data Management, Biostats, Quality, and Regulatory)
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal and written communications skills
- 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
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Ability to have fun and thrive in a growing, diverse and inclusive work environment!