Senior Regulatory Affairs Associate – Labelling

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

• Draft, modify, format, and uphold CCDSs and related labelling documents utilizing approved templates and standards.

• Prepare revisions to SmPCs, package leaflets, prescribing information, and text for cartons and containers.

• Ensure consistency throughout global and local labelling documentation.

• Apply regulatory and company guidelines to meet quality and compliance standards.

• Maintain version histories and document traceability through effective change management.

• Monitor, review, and reconcile changes across submission versions employing document comparison and review tools.

• Assist with CCDS updates and labelling modifications across various markets.

• Provide support for regulatory variations, Health Authority responses, and other lifecycle activities affecting product labelling.

• Contribute to labelling harmonisation initiatives and document remediation projects.

• Aid in the preparation of submission-ready labelling documentation within specified timelines.

• Ensure documents are accurate, complete, and properly formatted prior to review and submission.

• Implement Good Documentation Practices (GDP) and adhere to internal quality standards.

• Support the ongoing improvement of labelling templates, workflows, and authoring processes.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific field.

• Prior experience in Regulatory Affairs, pharmaceutical labelling, technical authoring, or a similar area.

• Familiarity with the structure, content, and upkeep of labelling documents.

• Experience in supporting the preparation and maintenance of regulatory documentation.

• Understanding of Good Documentation Practices (GDP) and quality management principles.

• Exceptional communication, stakeholder management, and interpersonal skills, with the capacity to collaborate effectively across cross-functional teams.

• Proficient in English, both in writing and speaking.

🏝️ Benefits

• Flexibility in working location across various European locations, whether in the office or remotely.