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.
The Director, Regulatory Operations will be responsible for planning, formatting, publishing, quality check, delivery and archiving of global regulatory submissions in accordance with agency requirements and company standards. Additionally, the position will provide administrative support for Regulatory systems.
The successful candidate must be able to perform each of the following satisfactorily:
- Lead role in ensuring the department plans, prepares, and tracks regulatory electronic documents and submissions
- Format, publish, and submit in eCTD format or paper to Health Authorities according to FDA/ICH requirements
- Responsible for identifying potential risks to submission plans and developing risk mitigation strategies
- Collaborate and consult with Regulatory Affairs and other departments on the content, review, and assembly of regulatory documentation and associated timelines
- Provide regulatory operations guidance and information to project and submission teams
- Ensure consistency, completeness, and adherence to agency guidelines, work instructions and SOPs
- Attend project team meetings, as needed, for compilation of submissions, Regulatory Operations guidance and establishing timelines
- Maintain the company archives of regulatory submissions and communications with health authorities
- Provide leadership for Regulatory-owned system support. Lead for new systems, software releases, maintenance, and upgrades.
- Provide end-user support and training for Regulatory owned systems.
- Bring and maintain expert knowledge of electronic submission and validation standard
- Assumes other relevant assignments as directed by the Head of Regulatory Operations
- Maintain tracking documents as well as publishing and submission calendars
- 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
- 15 years' experience in the pharmaceutical industry
- 10+ years in regulatory operations
- Experience with electronic submission building tools, document formatting and publishing standards
- Experience creating process improvements for a Regulatory Operations function within Regulatory Affairs.
- Experience validating and maintaining an eCTD Publishing System and/or Electronic Document Management System (EDMS) - Regulatory Information
REQUIRED KNOWLEDGE AND ABILITIES:
- Experience with electronic submissions, advanced PDF publishing tools, creating/maintaining templates, and management of EDMS
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g., FDA, EMA, ICH, etc)
- Experience mentoring/managing personnel is a plus (internal FTEs or vendor management)
- Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of PDF Processing Tools (ToolBox), eCTD validation and viewers
- Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
- Works independently, is able to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
- Ability to independently problem solve and offer solutions to functional leaders and collaborators.
- Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
- Effective communication skills, both verbal and written, with demonstrated ability to present and articulate requirements
- Exceptional attention to detail as well as organizational skills, including the ability to prioritize and multitask
- Strong project management skills and ability to work in a fast-paced environment.
- Ability to work through others to attain goals.
- May be required to work overtime in order to meet company deadlines, as needed
- 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!