Regulatory Submission Manager

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To strengthen our Regulatory Affairs function, based in our Anderlecht offices we are looking for a talented individual to fill the position of: Regulatory Submissions Manager.

As the Regulatory Submissions Manager, you will provide technical guidance to submission contributors and regional input regarding agency submission requirements.

You will contributeby:

• Being the main SPARK point of contact to all Practices and PSTs for a given product.
• Working in partnership with the SPARK team, for the definition and management of global and regional publishing strategies for their assigned product (s) to meet all regulatory submission requirements, ensuring that dossier structure, metadata and submission archives are compliant and consistent throughout the end-to-end submissions process, enabling effective re-use between submissions.
• Being responsible for working with Global Regulatory Affairs, Patient Solutions Teams, Practices, Affiliates and Partners to ensure regional delivery or publishing, document management, tracking and planning as required.
• Providing technical guidance to submission contributors and regional input regarding agency submission requirements.
• Publishing planning, working with authors to ensure submission readiness of documentation for assigned submissions and acts as product dossier historian.
• Leading or contributing to the development of global processes and standards for regulatory submissions and technology projects.

Interested? For this position you’ll need the following education, experienceand skills:

• Several years of experience in the pharmaceutical industry, with specific experience related to the preparation of regulatory dossiers and use of document management systems including electronic repository platforms with emphasis in submission publishing.
• Previous experience in the preparation of electronic submissions, including eCTD and other regional electronic formats with experience in managing eCTD lifecycles and validation.
• Experience in preparation of documents for regulatory submissions to meet authority requirements and company standards, including extensive knowledge of Microsoft Word and Adobe Acrobat functionality.
• Extensive knowledge of regional regulatory agency requirements for electronic submissions format and delivery including detailed knowledge of eCTD specifications and validation requirements. Some direct experience with regulatory agencies.
• Extensive knowledge of standard industry submission technologies (document management and publishing tools) and best practices related to submission preparation, archiving, and tracking.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.