Senior Regulatory Affairs Consultant – Regulatory Labeling Strategist

This is a fully remote position, open to applicants in United States.

📋 Description

• Define and implement the global labeling strategy across both foundational and non-foundational markets.

• Lead the development, revision, and management of essential labeling documents, including CDS, USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.

• Coordinate labeling content and strategy among U.S., EU, and global regulatory teams.

• Analyze clinical and scientific data to guide labeling content and product claims.

• Stay updated on global labeling regulations and provide training for stakeholders.

• Chair and manage the Labeling Review Committee, Global Labeling Committee, and CCDS Working Team.

• Establish and maintain governance frameworks for the company's labeling positions and foundational markets.

• Oversee operational labeling tasks, including artwork coordination, linguistic reviews, and U.S. SPL submissions.

• Maintain labeling documentation within eDMS and regulatory tracking platforms, ensuring adherence to version control, SOPs, and audit readiness.

• Manage change control documentation, specimen requests, and part-number verification.

• Ensure compliance with FDA Section 508 accessibility requirements for U.S. labels.

• Support regional implementation of CDS updates and monitor compliance across various markets.

• Address inquiries from Health Authorities and handle country-specific labeling variations.

• Prepare RFIs, differences tracking tables, and lead negotiations with Health Authorities.

• Review and approve advertising, medical education, and social media content for compliance.

• Manage and proofread artwork for foundational markets, TOLL, PAHO, and ASUs.

• Oversee mock-ups and production for combination products and devices.

• Lead annual strain updates for flu campaigns in both Northern and Southern Hemispheres.

• Manage labeling for U.S. Drug Listing Reports, including NDC assignments and annual reporting.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field.

• 5–7 years of experience in the biotech or pharmaceutical industry.

• 2+ years in global labeling/regulatory roles with strategic leadership responsibilities at a global level.

• Demonstrated capability to lead cross-functional teams and influence stakeholders across diverse cultural and geographical contexts.

• Comprehensive knowledge of regulatory labeling lifecycle management in the US, EU, DE, CH, and AU.

• Experience with direct-to-consumer advertising, social media review, and negotiations with Health Authorities.

• Familiarity with RIMS tools like Veeva RIMS; eDMS systems such as Veeva; Apollo; Docubridge; and change management systems like Trackwise.

• Proficient in Microsoft Office, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS.

• Understanding of regulatory requirements pertinent to drug development, global labeling, and post-marketing activities.

• Proven problem-solving skills, risk analysis capabilities, and sound decision-making.

• Strong collaboration abilities in global, cross-cultural, matrix environments.

• Excellent organizational and communication skills.

• Proficient regulatory knowledge, including understanding scientific concepts related to labeling and their global implications.

• Attention to detail paired with strategic thinking.

• Fluency in English, both verbal and written.

• Candidates located outside of EST must be flexible to provide coverage during EST hours.

• An advanced degree (MSc, PhD, PharmD) is preferred.

🏝️ Benefits

• Opportunity to influence the global labeling strategy and lead governance processes.

• A dynamic and collaborative work environment.

• Equal opportunity employer.

• Remote work available within the United States.