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- Tasks: Manage regulatory documents, ensuring they are compliant and submission-ready.
- Company: Shionogi is a leading pharmaceutical company focused on global healthcare innovation.
- Benefits: Enjoy a dynamic work environment with opportunities for personal development and collaboration.
- Why this job: Be part of groundbreaking healthcare advancements and contribute to meaningful projects.
- Qualifications: Experience in document management within the pharmaceutical industry is essential.
- Other info: Join a diverse team dedicated to making a positive impact on health worldwide.
The predicted salary is between 36000 - 60000 £ per year.
This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.
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.
Regulatory Operations Document Manager employer: Shionogi Europe
Contact Detail:
Shionogi Europe Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Operations Document Manager
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance and accuracy in document management.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with eCTD submissions and document management systems like Veeva. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest tools and technologies used in regulatory publishing. Being knowledgeable about innovations in document management can set you apart from other candidates and show that you're proactive about improving workflows.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed regulatory documentation in the past. Highlighting your attention to detail and ability to work under pressure will resonate well with the hiring team at Shionogi.
We think you need these skills to ace Regulatory Operations Document Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Operations Document Manager position. Tailor your application to highlight relevant experience in document management within the pharmaceutical industry.
Highlight Relevant Skills: Emphasise your expertise in Word formatting, PDF remediation, and familiarity with document management systems like Veeva. Provide specific examples of how you've successfully managed regulatory documentation in previous roles.
Craft a Compelling Cover Letter: Write a cover letter that not only showcases your qualifications but also reflects your passion for improving healthcare. Mention how your skills align with Shionogi's mission and values, and express your enthusiasm for contributing to their innovative projects.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. Attention to detail is crucial for this role, so ensure your application is polished and professional.
How to prepare for a job interview at Shionogi Europe
✨Showcase Your Document Management Skills
Be prepared to discuss your experience with document management systems, particularly any tools like Veeva or ISIToolBox. Highlight specific examples where you ensured compliance and accuracy in regulatory documentation.
✨Demonstrate Attention to Detail
Since this role requires a keen eye for detail, be ready to provide examples of how you've successfully managed complex documents. You might want to mention any challenges you faced and how you overcame them to ensure submission-ready documents.
✨Familiarise Yourself with eCTD Submissions
Understanding the eCTD format is crucial for this position. Brush up on what it entails and be ready to discuss your experience with electronic submissions. This will show your potential employer that you're proactive and knowledgeable.
✨Prepare Questions About Regulatory Innovations
Show your enthusiasm for the role by preparing insightful questions about Shionogi's ongoing initiatives in regulatory affairs and digital transformation. This demonstrates your interest in the company's mission and your eagerness to contribute.
