Senior Manager, Regulatory Affairs Strategic Global Labeling (Hybrid)

Job Description
The Senior Manager Labeling RA, Strategic Global Labeling, develops and maintains US package inserts (USPI), European Union (EU) Summary of Product Characteristics (SmPC) and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Mentors and educates cross-functional team members concerning global consistency of labeling with minimal supervision for more complex material but generally functions independently. Develops and presents strategy to management and leads a team to successfully execute regulatory strategies within a therapeutic area. Works with several cross-functional teams and often at director level. Supports multiple therapeutic areas and effectively leads cross-functional groups in the completion of project tasks and sub-projects. May manage direct reports.
Responsibilities:
Leads teams on labeling decisions based on knowledge of processes and regulations and precedence. Educates others regarding existing and new labeling regulations regarding CCDS, USPI, SmPC and Instructions for Use (IFUs).
Reviews and assesses data to determine whether accurate and reproducible. Works with Labeling Subteams to assure new and revised is included as support documentation following internal approvals. Works with cross-functional teams and affiliates to address Health Authority requests globally in a timely manner and resolves labeling issues.
Drives strategic labeling processes within Labeling Subteams based on knowledge of success with other products, proactively recommends optimal label language based on competitive knowledge and understanding of project data;
prepares Target ProductLabeling.
Maintains accurate files of labeling change history and associated documents within Cosmos, including annotated labels back to source data. Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA, ensures that direct reports are current with maintenance of their documents.
Coaches and guides direct reports on their job tasks and for career growth. Participates at team meetings, reviews materials, authors documents and trains staff. Reviews work of direct reports as needed.
Works with safety groups on safety issues and leads discussion on safety-related labeling changes. Makes decisions on assigned topics and those of direct reports based on experience with various products. Understands and supports regulatory implications on product profile. Works strategically with Global Regulatory Strategy and Safety to maintain an accurate safety profile for assigned products. Provides labeling input for Risk Management Plans, PSUR/PADER and safety documents.
Provides labeling support to global affiliates regarding pre-approvals, submissions, renewals and competitive analysis.
Presents process, strategy and product labeling at Senior level meetings including Regulatory Strategy Review (RSR), Regulatory Strategy Team (RST), Global Regulatory Product Team (GRPT), Labeling Review and Strategy Team (LRST), Executive Leadership Committee (ELC) and joint company meetings for third party agreements, all under the direction of the Director, Strategic Global Labeling.
Leveling of the role is flexible based on candidates experience.