Senior / Regulatory Affairs Consultant - Labeling

Senior / Regulatory Affairs Consultant - Labeling Global Regulatory Labeling Manager 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. Prepare administrative label updates for multiple markets (EU, US, AU, CH, DE).

Coordinate and manage EU administrative updates (e.g., 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. Prepare documents for Labeling Review Committee (LRC) and run LRC meetings.

Prepare Global Labeling

Committee (GLC) materials for endorsement and implement GLC decisions.

Regulatory

Submissions & Negotiations 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.

Special Projects

University degree (4-year)



in Life Sciences or related Pharmaceutical field (e.g., Advanced degree (MSc, PhD, PharmD) preferred. Minimum of 5-7 years in the biotech/pharmaceutical industry. At least 2+ years of labeling/regulatory experience with global responsibilities. Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.

Experience with direct-to-consumer and marketing advertising, educational materials, and social media.

Technical Systems Expertise: Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS. 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.

Organizational skills to interact seamlessly both internally and externally on compliance matters. Proficient regulatory knowledge, including scientific concepts within labeling and their global implications. Fluency in English (verbal and written); additional languages would be an asset.

This is an opportunity to make a global impact in regulatory affairs, ensuring patients worldwide receive accurate and compliant product information. Mid-Senior level Full time Pharmaceutical Manufacturing and Biotechnology Research

📌 Compliance Officers (Winnipeg)
🏢 Parexel
📍 Winnipeg