EU Regulatory Labelling Lead – Product Information

Scienta; Slough; On-site; GBP 90,000 - 120,000; Full time

Job summary

Scienta, in collaboration with a Global Leader in Biopharmaceuticals, seeks a Senior Manager Regulatory Labelling to own EU Product Information across the product lifecycle. You will ensure SmPCs, PILs, labelling and IFU remain accurate, compliant and aligned with EU regulatory requirements.

You will lead development and maintenance of EU Product Information, act as the EU labelling SME to guide cross-functional teams, and drive changes across European markets while overseeing readability

Qualifications

• 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.

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.

Skills

Regulatory affairs

EU labeling

Cross-functional collaboration

Regulatory guidance

Stakeholder influence

Job description

Scienta, in collaboration with a Global Leader in Biopharmaceuticals, seeks a Senior Manager Regulatory Labelling to own EU Product Information across the product lifecycle. You will ensure SmPCs, PILs, labelling and IFU remain accurate, compliant and aligned with EU regulatory requirements.

You will lead development and maintenance of EU Product Information, act as the EU labelling SME to guide cross-functional teams, and drive changes across European markets while overseeing readability