At a Glance
- Tasks: Manage regulatory systems and data to ensure compliance and efficiency in processes.
- Company: Mundipharma, a leader in innovative treatments with a collaborative culture.
- Benefits: Flexible benefits, learning opportunities, and a diverse, inclusive work environment.
- Other info: Join a dynamic team focused on growth and innovation.
- Why this job: Make a real impact in the pharmaceutical industry while developing your skills.
- Qualifications: Experience in regulatory affairs and proficiency in Veeva Vault RIM.
The predicted salary is between 60000 - 75000 £ per year.
Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
Role and Responsibilities
The Manager will be accountable for the strategy and management of all systems and data within the regulatory affairs function. You will be responsible for the strategy and oversight of the regulatory information management system (RIM) and oversight of the regulatory systems support group and regulatory submission management and publishing teams. You will also be responsible for regulatory data management and management of training and SOPs for regulatory. This role is also responsible for managing, developing and enhancing regulatory data management to ensure compliance, and to drive compliance and efficiencies in our regulatory processes using Veeva Vault RIM system. Working in a highly collaborative environment this role will engage with multiple areas of the business.
- Strategic oversight of the regulatory information management system
- Responsible for the ongoing strategy of the regulatory information management system
- Oversee the implementation, maintenance and optimization of Veeva RIM
- Identify opportunities to enhance RIM capabilities to streamline regulatory processes
- Collaborate with various stakeholders across the business to integrate RIM across the business
- Liaise with vendor(s) and Mundipharma IT to ensure that Veeva delivers optimally for the business, evaluating Veeva functionality and upgrades and impact on the business and its data
- Monitor changes in regulatory and industry requirements and assess the impact of those on RIM requirements
Regulatory Data ownership and reporting to the organization
- Develop reporting mechanisms to ensure that senior management have oversight of compliance and risks
- Utilize data analytics and reporting tools to track compliance metrics and generate actionable insights to senior management
- Advise on the optimal use of regulatory data and create dashboards, reports etc. for internal and external audiences using business analytics reporting tools
- Conduct audits and assessments to ensure regulatory data compliance
- Responsible for data maintained in external systems such as SPOR and the processes associated to maintaining the data
- Responsible for RA hard copy data management globally
Training and Process Development
- Set up and/or update regulatory affairs SOPs, instructions, and guides for the use of Veeva and for other RIM activities
- Deliver appropriate training for users, both internally and for external vendors
Management of submission management and publishing teams
- Oversight of the external submission management activities
- Evaluate new technologies for future enhancements and improvements and lead any plans for implementation
- Responsible for assessing budget requirements around regulatory data management requirements
What you’ll bring
- Proven experience working in the pharmaceutical industry in a regulatory/regulatory operations function
- Proficiency in using Veeva Vault RIM and experience in driving its implementation and enhancement
- Understanding global regulatory requirements and compliance standards
- Understanding the importance of regulatory data management
- Able to act independently and proactively problem solve
- Excellent written and verbal communication skills
- Ability to work in a fast-paced, dynamic environment
What we offer in return
- Flexible benefits package
- Opportunities for learning & development through our varied programme
- Collaborative, inclusive work environment
Diversity and inclusion: Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
Regulatory Affairs Systems and Data Manager in Cambridge employer: Mundipharma Research Limited
At Mundipharma, we pride ourselves on fostering a collaborative and inclusive work environment where every employee can thrive and contribute to meaningful innovations in healthcare. Located in the vibrant city of Cambridge, our flexible working arrangements and commitment to professional development ensure that you will have the support and resources needed to excel in your role as a Regulatory Affairs Systems and Data Manager. Join us to be part of a team that values diversity, encourages growth, and is dedicated to making a difference when it matters most.
Contact Details:
Mundipharma Research Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Systems and Data Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Mundipharma or similar companies. A friendly chat can open doors and give you insights that might just help you land that interview.
✨Tip Number 2
Prepare for the interview by researching the company and its values. Understand their approach to regulatory affairs and think about how your experience aligns with their goals. This will show them you're genuinely interested and ready to contribute.
✨Tip Number 3
Practice makes perfect! Get a friend to do a mock interview with you. Focus on articulating your experience with Veeva Vault RIM and how you've driven compliance in past roles. The more comfortable you are, the better you'll perform.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team and making a difference in regulatory affairs.
We think you need these skills to ace Regulatory Affairs Systems and Data Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Systems and Data Manager. Highlight your experience with Veeva Vault RIM and any relevant regulatory operations you've been involved in. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission at Mundipharma. Keep it engaging and make sure to connect your experiences to the job description.
Showcase Your Communication Skills:Since excellent written communication is key for this role, ensure your application is clear and concise. We love candidates who can articulate their thoughts well, so pay attention to grammar and structure. It reflects your professionalism!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. This way, your application goes directly to us, and we can review it more efficiently. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Mundipharma Research Limited
✨Know Your RIM Inside Out
Make sure you have a solid understanding of the regulatory information management system (RIM), especially Veeva Vault. Familiarise yourself with its functionalities and how it can enhance regulatory processes. Be ready to discuss specific examples of how you've used similar systems in the past.
✨Showcase Your Data Management Skills
Prepare to talk about your experience with regulatory data management. Highlight any tools or methodologies you've used to ensure compliance and efficiency. Bring examples of how you've developed reporting mechanisms or dashboards that provided actionable insights.
✨Emphasise Collaboration
This role requires working closely with various stakeholders, so be prepared to discuss your collaborative experiences. Share examples of how you've successfully engaged with different teams to integrate systems or improve processes, showcasing your ability to work in a highly collaborative environment.
✨Stay Updated on Regulatory Changes
Demonstrate your knowledge of current regulatory requirements and industry trends. Be ready to discuss how you've monitored changes in regulations and adapted your strategies accordingly. This shows your proactive approach and commitment to staying informed in a fast-paced environment.
