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Regulatory Labelling Manager

ROLE OVERVIEW

An exciting opportunity for a Hub Labeling Manager to join a leading biopharmaceutical organization, supporting the development, maintenance, and regulatory approval of product labeling across multiple markets. This role offers the chance to work within a dynamic team dedicated to ensuring compliance and quality in product documentation and labels, focusing heavily on innovative digital solutions to streamline processes.

Our client is seeking a highly skilled professional to manage labeling activities, collaborate on global and regional projects, and serve as a Subject Matter Expert on regulatory labeling requirements. Based in a flexible location, you will work closely with cross-functional teams and contribute to transforming regulatory data into an integrated, automated platform that supports the company’s digital transformation objectives.

KEY DUTIES AND RESPONSIBILITIE

Your duties as the Hub Labeling Manager will be varied however the key duties and responsibilities are as follows:

  • Oversee the preparation, review, and updating of labeling documents such as LPDs, LLDs, and PLDs for nationally registered products to ensure compliance with internal SOPs and external regulations.
  • Maintain and manage labeling systems, including GDMS and approved labeling tracking systems, ensuring data integrity and quality.
  • Produce and review labeling-related documentation for regulatory submissions, including track change versions, annotations, and comparison tables.
  • Act as a Subject Matter Expert on local, regional, and multi-country regulatory labeling requirements, providing guidance and input across projects.
  • As the Hub Labeling Manager, you will support digital initiatives, participate in research projects leveraging automation, machine learning, and process improvements to enhance labeling workflows.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Hub Labeling Manager we are looking to identify the following on your profile and past history:

  • A Degree or higher level in life sciences, pharmacy, or a related field; professional experience in regulatory affairs or labeling.
  • Proven ability to develop and manage labeling documents, with knowledge of global and regional regulatory guidelines.
  • Experience working with structured data systems, such as enterprise databases, MS Excel, SharePoint, or MS Access.
  • Strong communication skills in English are essential; multi-language abilities are advantageous.

WHAT’S IN IT FOR YOU?

This role provides the opportunity to work within a progressive organization committed to digital innovation and global health impact. You’ll gain valuable experience working on complex regulatory projects, contribute to cutting-edge process improvements, and influence product label strategies across multiple markets. Flexible work arrangements and exposure to advanced digital tools make this a highly appealing opportunity for a driven labeling professional.

Key Words: regulatory labeling / healthcare / digital transformation / project management / compliance / global regulations / process improvement / life sciences / pharmaceuticals / system management

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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