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 Director, Regulatory Labeling Lead. This position leads the Regulatory Labeling functions for assigned product(s) and manages all aspects of the end-to-end labeling process, including labeling strategy and content development, country labeling submissions, and implementations, globally.
The successful candidate must be able to perform each of the following satisfactorily:
- Manage the content development, review, and internal approval for new or revised Company Core Data Sheet (CCDS) and proposed US PI and EU PI.
- Lead and ensure effective planning of all Product Labeling Team (PLT) meetings, activities, and deliverables. Manage communication with Labeling Executive Approvers as appropriate.
- Drive labeling strategy in partnership with the Global Regulatory Lead in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, US PI, and EU PI.
- Responsible for labeling deliverables for NDA, MAA, and supplemental submissions to FDA, EMA, and Canada.
- Annotate CCDS and USPI as appropriate with references to supporting data/statement in the study report and summary documents in dossier.
- Ensure the quality and accuracy of the submission labeling documents - familiar with SRPI for US PI, QRD template/SmPC guideline for EU PI, and Canadian PM template
- Manage the submission-ready labeling documents and their workflow in VEEVA.
- Familiar with the preparation of SPL (Structure Product Labeling) for the required submission for Content of Labeling and Drug Establishment Registration and Listing in US
- Work with vendor on linguistic review and translations for EU MAA/variation submission and approval
- Manage the labeling discussion with FDA and EMA by leading the PLT in review the HA request/question and draft the response document or revised labeling for submission to HA. Track the labeling-related HA requests and responses in electronic database.
- Prepare final labeling upon or post HA approval as per regulatory requirement and Intercept internal process. Inform and provide final labeling to internal stakeholders as appropriate.
- Support responses to labeling-related inquiries from Global Health Authorities and related to inspection activities.
- Work with local operation/country regulatory representative in managing the development and revision to international country product information.
- Assist in reviewing proposed labeling documents for globally submissions and coordinate PLT review and alignment as needed.
- Assist in reviewing the HA inquiries or requests and coordinating PLT review and alignment if needed.
- Prepare the response documents for responding to HA as needed.
- Working with the vendor to prepare the translation as applicable.
- Provide QC/QA/proofreading as needed.
- Track the labeling-related HA requests and responses in electronic database.
- Support the development and revision of packaging artwork/mockups for NDA/MAA by providing the content of labeling and advise on the regulatory requirement for packaging.
- Manage the tracking and documentation in electronic data management systems.
- Manage the labeling repository and tracking.
- Create and maintain labeling SOP/processes and mentor/train new or junior staffs as needed.
- 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 a scientific discipline. Advanced degree preferred.
- Minimum of 8 years regulatory affairs relevant hands-on experience in global prescription drug regulatory labeling and packaging.
- Minimum of 10 years relevant industry experience.
REQUIRED KNOWLEDGE AND ABILITIES:
- Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making.
- Hands-on experience with US and EU prescription drug regulatory procedure and labeling requirement for NDA/MAA/supplemental submissions.
- Familiar with US and EU regulations relevant to prescription drug packaging development and implementation. Experience with international labeling requirement a plus.
- Proven ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
- Strong team leading and project management skills are essential.
- Excellent organization, detail oriented, and multi-tasking skills.
- Exceptional interpersonal skills and problem-solving capabilities. Adapt to changing environment.
- Ability to work independently and prioritize for efficiency.
- Ability to think creatively and excellent problem-solving skills.
- Knowledge of End-to-End Global Labeling Process
- Familiar with Electronic Data Management System, SharePoint, TVT or other text comparison tool, Excel, MS Word and PDF editing.
- 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