Regulatory Labeling Director
4 days ago
Job Summary:
We are seeking a highly skilled Regulatory Labeling Director to join our team at Madrigal Pharmaceuticals Corporation. As a key member of our regulatory team, you will be responsible for providing regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
Key Responsibilities:
* Provides regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
* Controls the consistency of labeling through review of content across the product family.
* Identifies areas of potential non-compliance and supports investigations as needed.
* Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes.
* Identifies potential non-compliance and supports investigations as needed.
* Leads and facilitates the global/regional labeling working groups to support the development of core and major regional labeling.
Global Labeling Compliance:
* Tracks compliance with established processes.
* Provides compliance data to department management, internal and external clients.
* Writes and tracks Corrective and Preventative Actions (CAPAs).
* Tracks and compiles department metrics.
United States (US) Labeling Operations:
* Provides regulatory expertise and guidance for the development and submission of US labeling components.
* Controls the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
* Manages FDA-required Structured Product Labeling (SPL) documents.
* Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork).
* Provides regulatory review and acts as text approver through alignment between approved content and artwork.
* Coordinates US labeling submission, approval and implementation activities through internal or client, systems and processes.
* Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Final Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.
Europe (EU) Labeling Operations:
* Provides regulatory expertise to regulatory teams on the development and submission of European labeling components for Health Authority review.
* Supports the consistency of European labeling through review of content in alignment with the core documents across product families.
* Manages and coordinates EU SmPC updates (contributors, systems, approvers etc.).
* Ensures that PI adheres to regulatory template/format of EU SmPC and provides subject matter expertise on associated guidelines and guidance documents.
* Manages translations, linguistic review process, and readability activities.
Qualifications:
* BS in life sciences in a healthcare field or equivalent experience, advanced degree strongly preferred.
* Minimum 10 years branded regulatory pharmaceutical drug development and labeling experience (with FDA, EMA, etc.).
* Broad based therapeutic area and product experience.
* Demonstrated experience interacting with global health authorities.
* Strong knowledge of regulations/guidelines governing global development of pharmaceuticals and labeling requirements is required.
* Excellent communication skills and proven negotiation skills.
* Must be able to effectively communicate with scientists at all levels and be able to present a scientific case to effectively communicate within the organization and/or regulatory agencies regarding labeling.
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
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