We are partnered with a Global Leader in Biopharmaceuticals in helping them find a Senior Manager Regulatory Labelling
You will take ownership of EU Product Information throughout the product lifecycle, ensuring the SmPC, PIL, Labelling and IFU remain accurate, compliant and aligned with EU regulatory requirements.
Key Responsibilities
- Lead the development and maintenance of EU Product Information, including SmPCs, PILs, labels and IFUs.
- Act as an EU labelling and regulatory SME, providing guidance to cross-functional and country teams.
- Lead reviews, approvals and implementation of labelling changes across European markets.
- Oversee readability testing, translations, linguistic reviews and artwork changes.
- Review promotional and non-promotional materials for compliance with EU regulations and approved product information.
Requirements
- 5–8 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Strong experience in EU labelling and Product Information across the product lifecycle.
- Experience with EU promotional review / advertising and promotion compliance.
- Strong knowledge of EU pharmaceutical regulations and regulatory procedures.
- Proven ability to work independently and influence cross-functional and senior stakeholders.
#J-18808-Ljbffr
Senior Manager Regulatory Labelling in Slough employer: Scienta
At Scienta, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a GCP QA Director, you will have the opportunity to lead critical quality initiatives in a global environment, supported by a commitment to employee growth and development through continuous learning opportunities. Our focus on inspection readiness and quality improvement not only enhances our clinical programs but also empowers our team members to make a meaningful impact in the field of clinical research.
