Senior Global Regulatory Labeling Strategist

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

📋 Description

• Offer strategic leadership and oversee global labeling operations.

• Spearhead the development of Target Product Labels (TPL) for early-stage assets.

• Create and manage Company Core Data Sheets (CCDS).

• Formulate regional labeling strategies and provide support for major markets including the US, EU, and Rest of World.

• Generate labeling content, formats, and ensure accountability for regulatory submissions, which encompass MAAs, supplements, and amendments.

• Verify that new labeling text adheres to regulatory labeling standards.

• Assist with Rest of World labeling evaluations in relation to the CCDS and prepare responses for Health Authorities.

• Collaborate with project teams to maintain consistent labeling processes and ensure local compliance with the CCDS.

• Articulate regulatory labeling strategies, risks, mitigation plans, and updates to global leadership, project development teams, and senior management.

• Contribute to the entire labeling process from start to finish.

• Lead and facilitate labeling team meetings, fostering strategic dialogue and managing content development.

• Provide support for other products during peak workload periods or in instances of team member absences.

• Collaborate with stakeholders across Regulatory, Clinical, Safety, Medical, and Commercial departments.

• Enhance medical and technical writing, ROW impact assessments, and cross-functional product development decisions.

• Ensure that high-quality, compliant labeling documentation is maintained throughout the product lifecycle.

⛳️ Requirements

• A Bachelor's degree in Life Sciences or a related field is mandatory.

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

• 7-10+ years of experience in the biotech or pharmaceutical sector.

• A minimum of 5-7+ years in global labeling/regulatory roles with leadership responsibilities on a global scale.

• Demonstrated capability to lead cross-functional teams and influence stakeholders in varied cultural and geographic contexts.

• Comprehensive understanding of current global regulations, particularly regarding vaccine development regulations and registration pathways.

• Prior experience in oncology or rare diseases is highly preferred.

• Significant experience with CTD format and content for regulatory filings.

• Direct experience in authoring, maintaining, and governing CCDS is essential, including oversight of global labeling updates and coordination for regional label implementation.

• Experience delivering labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.).

• Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise).

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

• Proven experience in facilitating meetings and achieving consensus and results.

• Exceptional leadership, communication (both verbal and written), and collaboration skills.

• Demonstrated proficiency in medical/technical writing.

• Experience with TPL work for early development programs and identified lifecycle programs.

• A strong sense of urgency regarding communications and response timelines with FDA/EMA/MHRA/other health authorities.

• High integrity and strong ethical standards.

• Results-oriented with a strategic mindset.

• Ability to adapt flexibly to diverse situations and collaborate with a variety of individuals and groups.

• Strong relationship-building, teamwork, and cooperative skills.

• Proficiency in English (both verbal and written); knowledge of additional languages is a plus.

• Candidates located outside the EST time zone must be flexible to provide coverage during EST hours.

🏝️ Benefits

• Consideration for equal opportunity employment.

• Chance to work across varied markets and therapeutic areas.

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

• A collaborative and dynamic work environment.

• Opportunity to contribute to innovative campaigns and enhance patient access to accurate product information.