Senior / Regulatory Affairs Consultant - Labeling

Senior / Regulatory Affairs Consultant - Labeling

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Parexel is seeking an experienced Global Regulatory Labeling Manager to collaborate with a dedicated client team and oversee complex global labeling initiatives.

In this role, you will lead and coordinate labeling activities across foundational and non-foundational markets, ensuring compliance with global regulatory requirements and supporting product lifecycle management. You will play a critical role in maintaining label governance, managing committees, and supporting advertising and promotional material reviews.

Key Responsibilities

Label Updates & Governance

• Prepare administrative label updates for multiple markets (EU, US, AU, CH, DE).
• Coordinate and manage EU administrative updates (e.g., address changes, Windsor updates).
• Develop, manage, and track governance for company positions (DLS, CCDS, USPI and EU SmPC) and foundational markets.
• Maintain multi-market manuscripts and dependent market lists.
• Provide strategic input to therapeutic area teams and influence external labeling landscape.

Compliance & Documentation

• Manage GRA label compliance processes, including QC and oversight of labeling performance.
• Maintain FDA-508 compliance on US labels.
• Prepare and manage change control documentation for foundational markets.
• Manage specimen requests and verify part numbers for correct labeling submissions.

Committee & Cross-Functional Leadership

• Prepare documents for Labeling Review Committee (LRC) and run LRC meetings.
• Prepare Global Labeling Committee (GLC) materials for endorsement and implement GLC decisions.
• Prepare documents for CCDS Working Team and run working Team sessions.

Regulatory Submissions & Negotiations

• Support label negotiations for foundational and other markets.
• Prepare differences tracking tables against CCDS or reference markets.
• Manage and track labeling HA requests and responses.
• Prepare RFIs and manage HA negotiations.

Advertising & Promotion

• Review and approve direct-to-consumer and marketing advertising, medical education, and social media content.
• Participate in promotional review committees, providing regulatory guidance aligned with local requirements.

Artwork & Safety Reporting

• Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs.
• Prepare, review, and approve mock-ups and artwork for production, including combination products/devices.
• Prepare labeling documents for safety reports (PSUR, PBER) and CH safety reports.

Special Projects

• Prepare annual strain updates for Northern and Southern Hemisphere flu campaigns.
• Manage labeling for US Drug Listing Reports, including NDC assignments and annual reporting.

Qualifications

Education:

• University degree (4-year) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering).
• Advanced degree (MSc, PhD, PharmD) preferred.

Experience:

• Minimum of 5-7 years in the biotech/pharmaceutical industry.
• At least 2+ years of labeling/regulatory experience with global responsibilities.
• Proven experience leading teams in a matrix organization.
• Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
• Experience in flu campaigns and pandemic products.
• Experience with direct-to-consumer and marketing advertising, educational materials, and social media.

Technical Systems Expertise:

• Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).
• Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.

Core Competencies:

• Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred).
• Demonstrated problem-solving ability with risk analysis and sound decision-making.
• Strong collaboration skills, with experience working in global, cross-cultural, matrix environments.
• Organizational skills to interact seamlessly both internally and externally on compliance matters.
• Proficient regulatory knowledge, including scientific concepts within labeling and their global i