Regulatory Operations Document Manager

Shionogi Europe; London; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a meticulous Document Manager to enhance regulatory documentation processes. This role offers a unique opportunity to contribute to the pharmaceutical industry's digital transformation, ensuring compliance and accuracy in regulatory submissions. You will collaborate with a dedicated team, leveraging your expertise in document management systems and formatting tools to optimize workflows. If you are passionate about making a difference in healthcare and thrive in a dynamic environment, this position is perfect for you.

Qualifications

• Experience as a Document Manager in the pharmaceutical industry.
• Proven expertise in Word formatting and PDF remediation.
• Excellent knowledge of document management systems.

Responsibilities

• Ensure regulatory documentation is accurate and compliant.
• Manage and organize regulatory documentation and submission files.
• Support implementation of new tools to streamline workflows.

Skills

Document Management

Word Formatting

PDF Remediation

Attention to Detail

Time Management

Tools

Veeva

ISIToolBox

Job description

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Description

Shape the Future of Healthcare with Shionogi

At Shionogi, we are dedicated to improving the health and well-being of people around the world. As a leading pharmaceutical company, we are committed to innovation, excellence, and making a positive impact on global healthcare. Join us in our mission to shape the future of healthcare and make a difference in the lives of millions.

Why Choose Shionogi?

Shionogi offers a dynamic, collaborative work environment where you can grow your career and contribute to groundbreaking healthcare advancements. We value diversity, inclusion, and the unique perspectives that each team member brings. At Shionogi, you will have the opportunity to work with talented professionals, engage in meaningful projects, and be part of a company that is at the forefront of medical innovation.

This position offers an opportunity for personal development, including the chance to take on more specialised responsibilities in regulatory publishing. As we continue to innovate and expand our digital transformation in Regulatory Affairs, you will have the opportunity to contribute to ongoing initiatives, optimise submission workflows, and enhance your expertise in electronic submissions and regulatory report publishing.

About the Role

As a Document Manager, you will play a crucial role in ensuring the accuracy, accessibility, and compliance of regulatory documentation. You will support the Regulatory Operations Team, including the Regulatory Affairs Submission Manager and the Head of the EU Regulatory Affairs Operations department. Your responsibilities will include:

• Formatting and remediating documents to ensure they are submission-ready and compliant with regulatory requirements.
• Managing, tracking, and organizing regulatory documentation, including eCTD submission files, key correspondences, and approval records.
• Acting as the regional point of contact for projects related to enhancements in regulatory information and document management systems.
• Supporting the implementation of new tools and technologies to streamline document workflows.
• Assisting regulatory colleagues in archiving key regulatory correspondences and submission-related records.
• Developing expertise in eCTD publishing and report generation, supporting the preparation and submission of regulatory dossiers.

What are we looking for?

We are seeking an experienced and detail-oriented individual with the following attributes:

• Expertise as a Document Manager (or in similar role) within the pharmaceutical industry.
• Proven expertise in Word formatting and PDF remediation to ensure documents are submission-ready.
• Excellent working knowledge and use of document management systems (e.g., Veeva) and formatting tools (e.g., ISIToolBox)
• Ability to work independently under pressure, demonstrating strong self-motivation and accountability.
• Excellent attention to detail and time management skills.

Join Us

If you are driven to make a tangible difference, please apply. Together, we can forge a path to a healthier world.