Senior Manager, Global Regulatory Affairs Labeling

Senior Manager, Global Regulatory Affairs Labeling

This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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100% remote in eastern or central time zone

The Senior Manager, Global Regulatory Affairs Labeling plays a key role in leading end-to-end labeling activities for commercial and development-stage programs in the rare disease space. This role contributes to the development, maintenance, and execution of global labeling strategies across the product lifecycle.

The Senior Manager acts as a core member of the Labeling Working Group (LWG), supporting the coordination of cross-functional discussions and driving alignment on proposed labeling updates. The individual provides regulatory input and strategic context to guide internal stakeholders on labeling development and revision considerations, ensuring alignment with health authority expectations and company standards.

• Drives End-to-End labeling process and strategy for the development, lifecycle management, and implementation of the TLP, CCDS, and local labeling (i.e., prescribing/patient information and packaging/artwork) in all markets to support successful commercialization and market expansion. Synthesizes labeling strategy through competitive landscape analysis, regulatory guidance, health authority feedback, and historical experience/labeling negotiations.
• Facilitates cross-functional stakeholder review and consensus of proposed labeling content via the Labeling Working Group and Labeling Review Committee (i.e., executive governance committee) prior to internal approval and/or submission of labeling to health authorities. Independently recommends labeling strategies including the evaluation of risk and mitigation strategies.
• Manages the preparation of submission-ready labeling and artwork components for all markets; consults with Regulatory Liaisons and other vendors regarding Health Authority requirements and evolving internal and external submission and negotiation plans.
• Ensures quality and compliant labeling and oversight via proper management of labeling files following the proper processes and utilizing available tools (e.g., document management system, QC of the CCDS and other labeling documents, and documentation of labeling tracking information).
• Supports all market-specific Health Authority labeling inspections, negotiations, and query responses and deviations and coordinates cross-functional alignment and approvals as needed.
• Identifies the need and contributes to the development of continuous improvement of business practices associated with labeling processes and tools.

• BS in scientific discipline or equivalent preferred. Advanced degree (MSc, PhD, PharmD, or JD) preferred, but not required.

• 7+ years of pharmaceutical industry experience. This is inclusive of approximately 5 years of pharmaceutical labeling experience (global, US, or EU) or a combination of 7+ years of regulatory and/or related experience (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.)

• Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling and artwork, including EU, US, and ROW labeling requirements and guidance and demonstrated ability to understand implications of label changes on pending and approved labels.
• Expertise in the development and maintenance of Target Product Profiles (TPPs), CCDS, USPI, EU SmPC/PIL, and ROW labeling.
• Proficiency in labeling tools, such as Electronic Document Management Systems, End-to-End (E2E) Labeling Trackers, and Artwork Management Systems to support labeling documentation, tracking, and compliance activities.
• Excellent written and verbal communication skills for effective communication with cross-functional stakeholders, Health Authorities, and adoption of complex data and scientific information into patient and prescribing information.
• Ability to build, engage, collaborate and interface directly within Regulatory, as well as with cross-functional teams and senior management as appropriate on labeling content and requirements and negotiate and influence where necessary.
• Proven ability working on innovative products and independently…