A leading pharmaceutical company focused on the development and distribution of high-quality, compliant medicines across global markets. To support the regulatory and product launch activities, we are seeking a skilled Labelling Specialist with a strong background in regulatory labelling in accordance with EMA, MHRA, and FDA requirements.
Key Responsibilities:
- Prepare, review, and maintain labelling documents in compliance with EMA, MHRA, and FDA regulatory requirements.
- Ensure timely updates to product information (SmPCs, PILs, labels, etc.) following regulatory changes and approvals.
- Collaborate with Regulatory Affairs, Quality Assurance, Medical Affairs, and Supply Chain teams.
- Support the development and maintenance of Core Labelling Documents (CCDS/CCSI).
- Contribute to labelling strategies for new product submissions, variations, and renewals.
- Review artwork for packaging to ensure regulatory compliance.
- Track labelling changes and implementation timelines across regions.
Requirements:
- Minimum 3-5 years of experience in regulatory labelling within the pharmaceutical industry.
- Proven expertise in labelling regulations and procedures under EMA, MHRA, and FDA.
- Strong understanding of regulatory submission types (e.g., MAAs, variations, supplemental NDAs).
- Excellent attention to detail and written communication skills.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).
Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.
We do not ask for a placement fee from Candidates/Employees.
If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09
Greg King