Associate Director, Global Regulatory Labeling
1 week ago
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned products. This position ensures that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on strategic and operational decisions.
Responsibilities
Acts as point of contact for cross-functional teams on global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS). Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.
Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for assigned products. Manages US/EU and local country labeling deviations from CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.
Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format. Follows internal processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.
Establishes Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.
Department Coordination: Builds cross-functional and cross-regional relationships.
Education Qualifications (from An Accredited College Or University)
Bachelor's Degree preferably in a scientific discipline required
advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred
Experience Qualifications
7 or More Years pharmaceutical industry experience required
4 or More Years of direct regulatory affairs experience, including US labeling experience required
Experience with ex-US labeling (outside the US) preferred
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