Labelling Strategist/ Product Labelling Specialist

hace 3 semanas

Pontevedra, España Smartedge Solutions A tiempo completo

Smartedge’s Client is looking for an individual to help with their Labelling Strategist/ Product Labelling Specialist @ Spain (100 % Remote Working)

Experience Required :

Responsible for the review, development, and maintenance of pharmaceutical product labeling to ensure compliance with global regulatory requirements, internal standards, and market needs. This includes managing updates to labeling content, coordinating cross-functional input, and supporting product launches and lifecycle changes.

Key Responsibilities:

- Label Content Management:
- Review and update product labels, cartons, and inserts in accordance with FDA, EMA, CDSCO, and other global regulatory requirements.
- Ensure labeling reflects accurate product information including indications, contraindications, dosage, warnings, and usage instructions.
- Regulatory Compliance:
- Monitor changes in labeling regulations and assess impact on existing products.
- Conduct gap assessments and develop remediation plans to maintain compliance.
- Cross-Functional Collaboration:
- Work with Regulatory Affairs, Quality, Marketing, Legal, and Manufacturing teams to gather input and finalize labeling content.
- Lead or support labeling-related projects such as new product launches, market expansions, or regulatory updates.
- Documentation and Systems:
- Maintain labeling records in electronic document management systems (e.g., Veeva Vault, SmartSolve).
- Initiate and manage Change Control documentation for labeling updates.
- Quality and Process Improvement:
- Support audits and inspections by providing labeling documentation and ensuring traceability.
- Contribute to the development and revision of SOPs related to labeling processes.
- Need to know English & Spanish language and Spain regulations

If this sounds like a role you would be interested in or if you know someone in this field.

Connect with me or email me at

Alternatively, you can call me on Tel: +44(0) .

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