Location: Remote (Anywhere in the EU)
Contract: 12 months
Start Date: January
Hours: Full-time, 37.5 hours per week (Monday–Friday)
Experience Level: 5 years Regulatory Affairs
Languages: Fluent Spanish + Fluent English required
Pay rate: Dependent on experience! Please enquire.
Contact: Alex Roberts – aroberts@axion-search.com – 07572302937 (whatsapp me!)
Axion Search is seeking an experienced RA Labelling Strategist to support regulatory labelling activities across EU markets, with a specific focus on Spanish labelling requirements and AEMPS regulations. This role is fully remote within the EU and ideal for a senior Regulatory Affairs professional with strong labelling expertise and cross-functional project experience.
The successful candidate will manage labelling content, ensure compliance with global and local regulations, and lead labelling updates across multiple product portfolios.
Key Responsibilities
Label Content Management
- Review, update, and approve product labels, leaflets, cartons, and inserts in alignment with FDA, EMA, CDSCO, AEMPS, and other global regulatory standards.
- Ensure labelling reflects accurate and compliant information on indications, contraindications, dosage, warnings, and instructions for use.
- Develop and maintain the Company Core Data Sheet (CCDS) and ensure local implementation.
Regulatory Compliance
- Monitor national and international updates to labelling regulations, particularly Spain-specific requirements.
- Conduct gap analyses for existing products and develop remediation plans.
- Support compliance activities related to UDI (Unique Device Identification) and GS1 standards.
Cross-Functional Collaboration
- Partner with Regulatory Affairs, Quality, Medical, Marketing, Legal, and Manufacturing teams to gather inputs and finalise labelling content.
- Lead or support labelling projects for new product launches, variations, renewals, and market expansions.
- Provide regulatory labelling expertise during audits, inspections, and internal reviews.
Documentation & Systems
- Maintain complete labelling documentation within electronic document management systems (e.g., Veeva Vault, SmartSolve).
- Prepare and manage Change Control documentation related to labelling updates.
- Ensure full traceability and version control for all labelling components.
Quality & Process Improvement
- Support internal and external audits through accurate documentation and compliance evidence.
- Contribute to process improvement initiatives, including updates to SOPs and work instructions.
- Ensure alignment with corporate labelling standards and global frameworks.
Qualifications & Experience
Required
- Bachelor’s degree in Pharmacy, Life Sciences, or related scientific field.
- 5 years of experience in Regulatory Affairs with a focus on labelling, product information, or lifecycle management.
- Fluency in Spanish and English (written and spoken).
- Strong understanding of EU labelling requirements, including Spain (AEMPS).
- Experience working with FDA/EMA/Global regulatory frameworks.
- Proficiency with Microsoft Office and labelling systems (e.g., Adobe InDesign, BarTender).
- Excellent accuracy, attention to detail, and proofreading skills.
- Strong project management and ability to manage multiple workstreams.
Preferred
- Experience developing or managing CCDS / CCSI documents.
- Knowledge of EU MDR, UDI, and GS1 standards.
- Experience working with cross-functional, global teams.
- Technical writing background.
