Intercept Pharmaceuticals Senior Manager, Regulatory Labeling in San Diego, California
The Senior Manager, Regulatory Labeling will partner with the Head of Regulatory Labeling and Promotion at Intercept and be responsible for supporting the content development, review, and internal approval of the proposed labeling (Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Prescribing Information (Pl).
This position will also support the work related to labeling negotiation with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during review of the NDA/MAA and the labeling-related activities.
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 the Product Labeling Team (PLT) and manages the PLT meetings and deliverables. Manage communication with Labeling Executive Approvers as appropriate.
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.
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
Bachelor’s degree in a scientific discipline. Advanced degree preferred.
Minimum of 6 years relevant industry experience with bachelor’s degree; 4 years relevant industry experience with advanced degree.
Minimum of 4 years hands-on experience in global pharmaceutical, prescription drug regulatory labeling strategy, operation, and packaging.
REQUIRED KNOWLEDGE AND ABILITIES:
Working knowledge of the scientific principles of the drug development process.
Working knowledge of US and EU regulations relevant to prescription drug labeling and packaging. Experience with international labeling and packaging requirement a plus.
Experience in manufacturing process as related to packaging, e.g., product development, supply chain, QA, etc.
Familiar with US and EU prescription drug labeling requirement for NDA/MAA submission.
Familiar with Electronic Data Management System, SharePoint, TVT or other text comparison tool, Excel, MS Word and PDF editing.
Strong verbal and written communication skills are essential.
Good organization, detail oriented, multi-tasking, and project management skills.
Good interpersonal skills and problem-solving capabilities.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to adapt to the changing environment and work 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!
Keyword: Senior Manager, Regulatory Labeling
From: Intercept Pharmaceuticals