Senior Regulatory Labeling Specialist

🏗 We're Hiring: Senior Regulatory Labeling Specialist

📍 Location: United Arab Emirates (Remote)

🕒 Employment Type: Full-Time

💼 Experience Level: Mid-Level to Senior

🌐 Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of operational excellence, regulatory compliance, risk management, and business continuity.

We recognize the importance of accurate documentation, clear communication, effective risk management, and adherence to applicable regulatory requirements across complex operational environments. Through strong governance, standardized procedures, and continuous improvement, we aim to protect stakeholders, strengthen accountability, and support consistent quality throughout our activities.

The Role

We are seeking an experienced Senior Regulatory Labeling Specialist to manage pharmaceutical product labeling activities, regulatory labeling submissions, product information updates, and labeling compliance across applicable markets. The successful candidate will coordinate the development, review, approval, implementation, and maintenance of product labeling documents to ensure alignment with approved product information, current safety data, regulatory requirements, and organizational standards.

This role requires strong knowledge of pharmaceutical labeling regulations, product information management, regulatory submissions, change control, and cross-functional coordination. The specialist will collaborate with Regulatory Affairs, Medical Affairs, Pharmacovigilance, Drug Safety, Quality Assurance, Manufacturing, Supply Chain, and other stakeholders to maintain accurate, consistent, and compliant labeling throughout the product lifecycle.

Key Responsibilities

• Manage end-to-end regulatory labeling activities for pharmaceutical products, including new registrations, product lifecycle changes, safety updates, and periodic label reviews.
• Develop, review, and maintain product labeling documents in accordance with applicable regulatory requirements and approved internal procedures.
• Coordinate the preparation and maintenance of Summary of Product Characteristics (SmPCs), package leaflets, patient information leaflets, prescribing information, and other applicable product information documents.
• Support the preparation and maintenance of outer packaging, immediate packaging, container labels, cartons, and other regulated labeling components.
• Ensure that labeling content accurately reflects approved product information, clinical evidence, product characteristics, and applicable safety requirements.
• Review labeling documents for completeness, accuracy, consistency, readability, and compliance with relevant regulatory standards.
• Maintain consistency between approved labeling, regulatory dossiers, product specifications, safety documentation, and other controlled product records.
• Coordinate labeling activities for new product registrations, line extensions, additional strengths, new formulations, and new indications.
• Support regulatory labeling requirements for product launches, market expansions, transfers, and changes in product ownership.
• Review regulatory approval conditions and ensure that required labeling commitments are accurately documented and implemented.
• Monitor regulatory requirements issued by relevant health authorities in the United Arab Emirates and other applicable markets.
• Maintain awareness of relevant international labeling guidelines, regional requirements, and pharmaceutical regulatory developments.
• Assess the impact of new or revised regulations, guidance documents, and authority expectations on existing product labeling.
• Support compliance with applicable requirements established by UAE health authorities and other relevant regulatory agencies.
• Interpret regulatory labeling requirements and communicate their practical implications to internal stakeholders.
• Maintain a regulatory labeling requirements matrix covering applicable markets, product categories, document types, and approval conditions.
• Coordinate with Regulatory Affairs colleagues to confirm country-specific labeling requirements, submission formats, language requirements, and implementation timelines.
• Prepare and maintain labeling submission documentation in accordance with applicable regulatory procedures.
• Support the preparation of labeling variations, amendments, notifications, and other regulatory submissions involving product information changes.
• Ensure that labeling changes are submitted through the appropriate regulatory pathways and within required timelines.
• Track labeling submission status, authority questions, approval dates, implementation deadlines, and outstanding commitments.
• Coordinate responses to regulatory authority questions regarding labeling content, safety statements, product information, and document consistency.
• Maintain complete records of regulatory correspondence, submission packages, approvals, and associated labeling decisions.
• Review approved product information against proposed labeling changes to identify discrepancies and ensure accurate implementation.
• Manage the incorporation of approved safety updates into product labeling in coordination with Pharmacovigilance and Drug Safety teams.
• Evaluate new safety information, emerging risks, and regulatory safety communications for potential labeling impact.
• Coordinate the review of adverse drug reaction information, contraindications, warnings, precautions, interactions, and other safety-related labeling sections.
• Support the implementation of safety-related labeling changes resulting from periodic safety reviews, signal assessments, benefit-risk evaluations, and regulatory authority decisions.
• Ensure that safety information is reflected consistently across relevant product information documents and markets.
• Collaborate with qualified medical and safety personnel to clarify clinical terminology and confirm the accuracy of proposed safety statements.
• Maintain traceability between safety assessments, regulatory decisions, approved changes, and implemented labeling updates.
• Support the preparation and review of labeling changes related to new clinical data, updated indications, revised dosing recommendations, and changes in product use.
• Assess the impact of changes in clinical evidence, product characteristics, manufacturing processes, and approved specifications on existing labeling.
• Coordinate labeling reviews associated with formulation changes, new presentations, new packaging configurations, and product lifecycle extensions.
• Ensure that labeling accurately reflects approved indications, dosage instructions, administration methods, contraindications, precautions, and storage requirements.
• Review product composition, strength, pharmaceutical form, route of administration, and other critical product details for consistency.
• Coordinate with Quality Assurance and Manufacturing to ensure that product labeling reflects approved product specifications and controlled manufacturing information.
• Support the assessment of labeling implications arising from manufacturing site transfers, supplier changes, packaging material changes, and other technical variations.
• Ensure that product identification details, batch information requirements, expiry date formats, storage statements, and other applicable labeling elements are accurate.
• Review packaging artwork and labeling proofs to verify consistency with approved regulatory content.
• Check that product names, active ingredients, strengths, dosage forms, warnings, symbols, barcodes, and other required information are presented correctly.
• Verify the accuracy of multilingual labeling content and coordinate language reviews where required.
• Ensure that translations preserve the intended medical meaning and comply with applicable country-specific terminology requirements.
• Coordinate with approved translation providers and local regulatory teams to resolve discrepancies in translated product information.
• Maintain consistency between master labeling documents and market-specific labeling versions.
• Support the development and maintenance of company labeling standards, style guides, templates, and terminology conventions.
• Ensure that labeling documents follow approved formatting requirements, document structures, and controlled terminology standards.
• Maintain accurate labeling version histories and ensure that obsolete documents are withdrawn or clearly identified according to document control procedures.
• Manage labeling change requests from initiation through assessment, review, approval, implementation, and closure.
• Document the rationale, regulatory impact, risk assessment, and implementation requirements for each labeling change.
• Coordinate cross-functional reviews of proposed labeling changes with Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, Supply Chain, Manufacturing, and other relevant teams.
• Obtain appropriate technical, medical, regulatory, quality, and business approvals before finalizing labeling documents.
• Maintain clear records of review comments, resolutions, approvals, and change implementation decisions.