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- Tasks: Manage regulatory systems and data, ensuring efficiency and compliance.
- Company: Mundipharma is a global healthcare leader focused on innovative treatments.
- Benefits: Enjoy flexible benefits, learning opportunities, and a collaborative work environment.
- Why this job: Make a real impact in healthcare while growing in a diverse and inclusive culture.
- Qualifications: Experience in regulatory operations and excellent communication skills required.
- Other info: This is a hybrid role based in Cambridge with permanent employment.
The predicted salary is between 36000 - 60000 £ per year.
ARA-P3-12 Job Title: Regulatory Affairs & Systems Data Manager Location: Cambridge (Hybrid/Flexible) Job type: permanent 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. 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 also management of training and SOPs for regulatory. Role and responsibilities Overall strategy of the regulatory systems ensuring they are fit for purpose for the function and wider organisation Oversight of the RIM system including management of routine maintenance and system validation working with the Mundipharma IT team Responsible for the external regulatory systems support team and ensuring their delivery. Responsible for the ongoing strategy of the regulatory information management system including; Evaluate new technologies for future enhancements and improvements and lead any plans for implementation. Evaluate changes in regulatory guidance and highlight impact and impact strategy management to senior leaders. Responsible for leading any corresponding regulatory guideline impact implementation. Responsible for updates to the RIM system or processes required by the business Responsible for providing budget requirements for RIMS system Oversight of the external data squad team Management of submission management and publishing teams Oversight of the external submission management team and external publishing team Regulatory Data ownership and reporting to the organization Responsible for proactively leading data and process analysis to identify areas to increase efficiency and automation of processes Manipulate, analyse and interpret Regulatory Affairs data, creating dashboards, graphs and visualisations. Prepare reports for internal and external audiences using business analytics reporting tools. Responsible for Data maintained in Mundipharma RIM and external systems (SPOR) and the processes associated to maintaining the data Responsible for reviewing vendor metrics and managing delivery with the regulatory team and vendor management team What you’ll bring Proven experience in regulatory operations, data, and system management Excellent understanding of Regulatory processes, dependencies and risks Detail oriented Highly organised Self-motivated, driven with a positive attitude. Excellent communication skills. What we offer in return Flexible Benefits Allowance opportunities for learning & development 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, as we focus on making a positive difference for our customers and their patients. About Mundipharma Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do. Join our talent pool If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles. Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2024-10-16 Job Type: Permanent
Regulatory Affairs Data and Systems Analyst employer: Mundipharma
Contact Detail:
Mundipharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Data and Systems Analyst
✨Tip Number 1
Familiarize yourself with the latest regulatory guidelines and technologies relevant to regulatory affairs. This knowledge will not only help you understand the role better but also demonstrate your proactive approach during discussions.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with regulatory information management systems (RIM). Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Showcase your analytical skills by preparing examples of how you've previously manipulated and interpreted data in a regulatory context. Being able to discuss specific instances where you've increased efficiency or improved processes will set you apart.
✨Tip Number 4
Research Mundipharma's current projects and initiatives in regulatory affairs. Understanding their strategic goals will allow you to tailor your conversations and show how your skills align with their objectives.
We think you need these skills to ace Regulatory Affairs Data and Systems Analyst
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Affairs Data and Systems Analyst position. Understand the key responsibilities and required skills, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your proven experience in regulatory operations, data management, and system oversight. Use specific examples that demonstrate your understanding of regulatory processes and your ability to manage data effectively.
Showcase Communication Skills: Since excellent communication skills are crucial for this role, make sure to highlight any relevant experiences where you successfully communicated complex information to various stakeholders. This could include reports, presentations, or team collaborations.
Tailor Your Application: Customize your cover letter to reflect your motivation for applying to Mundipharma specifically. Mention their commitment to innovative treatments and how your values align with their focus on integrity and patient-centricity.
How to prepare for a job interview at Mundipharma
✨Understand Regulatory Processes
Make sure you have a solid grasp of regulatory processes, dependencies, and risks. Be prepared to discuss how your experience aligns with these aspects and how you can contribute to the overall strategy of the regulatory systems.
✨Showcase Data Management Skills
Highlight your experience in data management and system oversight. Be ready to provide examples of how you've manipulated, analyzed, and interpreted regulatory data in previous roles, and how you created visualizations or reports for stakeholders.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss specific instances where you've identified areas for efficiency improvements or automation in regulatory processes. This will show your proactive approach and ability to lead change within the organization.
✨Communicate Effectively
Excellent communication skills are crucial for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory topics. Be ready to explain how you would communicate updates and strategies to senior leaders.
