Senior / Regulatory Affairs Consultant - Labeling

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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:

•             Prepare deviation documentation for non-foundational markets (DTT).

•             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 implications.

•             Effective communication skills for explaining concepts, options, and impacts.

•             Attention to detail with the ability to think strategically.

•             Fluency in English (verbal and written); additional languages would be an asset.

Why Join Us?

This is an opportunity to make a global impact in regulatory affairs, ensuring patients worldwide receive accurate and compliant product information. You will work across diverse markets, lead critical governance processes, and contribute to innovative campaigns in a dynamic, collaborative environment.

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