Senior Manager Regulatory Labelling

Scienta; Brussel; Sur place; EUR 120 000 - 150 000; Plein temps

Résumé du poste

Scienta partners with a Global Leader in Biopharmaceuticals to appoint a Senior Manager Regulatory Labelling responsible for EU product information lifecycle, ensuring SmPC, PIL, Labelling and IFU stay accurate and compliant with EU rules.

You will lead EU Product Information development, act as SME for EU labelling, guide cross-functional teams, and oversee translations, readability testing and artwork changes across European markets.

Qualifications

• 5–8 years of Regulatory Affairs experience in pharma/biotech.
• Strong experience in EU labelling and Product Information across lifecycle.
• Experience with EU promotional review / advertising compliance.
• Strong knowledge of EU pharmaceutical regulations and regulatory procedures.
• Proven ability to work independently and influence cross-functional and senior stakeholders.

Responsabilités

• 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.

Connaissances

Regulatory Affairs

EU Labelling

Product Information

Translations

Readability Testing

Artwork Changes

Promotional Review

Stakeholder Management

Description du poste

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.