Regulatory Submission Manager

il y a 3 semaines

Anderlecht, Belgique UCB S.A. Temps plein

**Make your mark for patients**

We are looking for a **Regulatory Submission Manager **to join us in our **Regulatory Affairs** team, based in either our **Brussels** (Belgium) or **Slough** (UK) offices.

**About the role**

The Submission Manager will be 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.

**What you’ll do**
- Perform publishing and/or compilation activities for reports and for submissions to Regulatory Authorities using existing technology and in accordance with internal business processes and regulatory requirements to meet designated timelines.
- Produce the electronic output for submissions and conduct technical validation to ensure compliance with authority requirements. Produce other outputs eg. paper / CDs where required.
- Manage all technical aspects for assigned submissions
- QC the work performed by other publishers as required. Ensure quality, completeness, and adherence to regulatory submission guidelines.
- Coordinate and track delivery of submissions to affiliates/partners or regulatory authorities and confirm receipt of the submissions upon request.
- Transmits Health Authority Submissions in most efficient, compliant and cost-effective manner e.g. using Agency Electronic Gateways.
- Collaborate cross-functionally with contributing stakeholders e.g. Drug Safety, Technical Operations, Clinical, Patient Solution Teams, Partners and Affiliates.
- Define and manage publishing and documentation strategies to meet all regional requirements and enable effective re-use between submissions.
- Collaborate with regional counterpart to ensure global consistency in dossier strategy and business processes where applicable maintaining a global core dossier for assigned products.
- Responsible for all major submissions, ensuring that regulatory submission guidelines are followed and that dossier structure, metadata and submission outputs are compliant and consistent.
- Responsible for contact with regulatory authorities, on topics related to submissions delivery and formatting, in support of product-specific Regulatory Affairs staff as appropriate.
- Lead or participate as a SME in the development of global processes and standards for regulatory submissions and technology projects to ensure that they meet evolving agency requirements and corporate quality standards as assigned. This may include business process documentation, system testing, validation, assisting with pilot submissions.

I**nterested? For this position you’ll need the following education, experience and skills**:

- Bachelor’s degree
- 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.
- Several years of experience in the preparation of electronic submissions, including eCTD and other regional electronic formats with experience in managing eCTD lifecycles and validation
- Ability to bring complex assignments through to completion
- 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.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportun

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