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 2021.
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 Senior Manager, Regulatory Operations. The Regulatory Operations Senior Manager will be responsible for the daily operational activities for global regulatory submissions and archives in accordance with agency requirements and company standards. Provide system administration support of the Electronic Document Management System (EDMS).
The successful candidate must be able to perform each of the following satisfactorily:
- Manage and performs daily operational activities for global regulatory submissions (project management, resource scheduling, formatting, publishing, QC, archive and submission)
- Collaborates with interdisciplinary teams, international colleagues, vendors and Regulatory Affairs in the management of submission components and tracking of deliverables
- Ensure consistency, completeness, and adherence to agency guidelines, internal work instructions and SOPs
- Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
- Evaluate, author and review SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
- Stay current with new electronic submission and regulatory documentation practices issued from global health authorities
- Author, review and maintain training materials for Regulatory systems
- Provide companywide individual and group training on EDMS
- Review, test, and implement new software releases and upgrades for Regulatory owned systems
- 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 with 8 years of experience in the pharmaceutical industry, 6+ years in regulatory operations, preferred; or equivalent combination of education and industry experience.
- Experience with electronic submission building tools, document formatting and publishing standards
- Experience using electronic document management system (EDMS)
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 specification (FDA, HC, EMA, ICH, etc)
- 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 independently, is able to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure
- 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
- May be required to work overtime in order to meet company deadlines, as needed
- 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
- Ability to have fun and thrive in a growing, diverse and inclusive work environment