Labeling Strategist – Regulatory Affairs AD

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

📋 Description

• Define and oversee authoring plans in collaboration with the Global Regulatory Lead and Project Managers.

• Direct global labeling strategies alongside cross-functional regulatory teams in the US, EU, and Japan.

• Create target product labels, Company Core Data Sheets, core IFUs, US labels, prescribing information, patient information, and associated documents.

• Organize and document labeling working groups and global labeling committees.

• Participate in and contribute to Global Regulatory Team meetings and submission teams.

• Review and provide input on label source documents, regulatory submissions, clinical documents, safety reports, and related materials.

• Formulate global labeling implementation plans in conjunction with Labeling Operations Managers.

• Oversee US mock-ups and Structured Product Labeling activities.

• Assess global and US labeling impact evaluations and assist with database documentation.

• Aid in the preparation of local dossiers and responses to inquiries from Health Authorities.

• Support the publication of the labeling section within US eCTD dossiers.

• Act as the Chairperson for the Global Labeling Committee and supervise committee requests.

• Serve as the global labeling expert within Safety Management Teams.

• Manage labeling contributions to PSUR/PBRER, PSMF, US annual reports, and other regulatory processes.

• Develop, contribute to, and maintain procedures related to labeling.

• Engage in pharmacovigilance inspector or auditor interviews.

• Offer technical advice and review for regional and global regulatory submissions.

• Guide internal and external clients on regulatory strategy, legislation, and guidance.

• Ensure quality performance and compliance for projects under management.

• Oversee project budgeting, forecasting, and identification of out-of-scope contract activities.

• Collaborate with business development on client presentations, proposals, pricing, and budgets.

• Lead matrix/project leadership, training, and mentorship for junior team members.

• Facilitate launch, review, project-team, and departmental initiative meetings.

⛳️ Requirements

• Bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

• Minimum of 5 years of experience in global labeling strategy.

• Prior experience with biologic products, medical devices, or combination products.

• Previous involvement in clinical development and/or a global regulatory affairs setting.

• 12+ years of relevant knowledge, skills, and abilities to fulfill the job responsibilities.

• An equivalent combination of suitable education, training, and/or directly related experience may be taken into account.

• Profound understanding of clinical development and comprehensive labeling processes.

• Familiarity with eCTD dossiers, labeling content, and management of labeling compliance.

• Knowledge of regulatory, labeling, and clinical intelligence databases.

• Understanding of Regulatory Information Management Systems and Electronic Document Management Systems, such as Veeva Vault.

• Proficiency in Adobe Acrobat Pro, Microsoft Word, Excel, and PowerPoint.

• Excellent command of English in both written and oral communication, as well as the local language when applicable.

• Strong attention to detail along with editorial and proofreading capabilities.

• In-depth knowledge of global, regional, and national regulatory requirements and procedures.

• Expert understanding of ICH and other international regulatory guidelines.

• Advanced comprehension of medical terminology, statistical concepts, and guidelines.

• Solid understanding of budgeting and forecasting principles.

• Demonstrated skills in professional negotiation, presentation, organization, time management, analysis, investigation, and problem-solving.

• Capacity to work independently, exercise sound judgment, and manage multiple projects simultaneously.

🏝️ Benefits

• Fully remote work opportunity.

• Standard Monday–Friday work schedule.

• Occasional travel for domestic and international engagements.