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- Tasks: Manage regulatory systems and optimise processes to ensure compliance and efficiency.
- Company: Join a rapidly growing UK pharmaceutical company dedicated to improving patients' lives.
- Benefits: Competitive salary, generous holiday, pension scheme, and wellness support.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: Bachelor's degree and 2 years of experience in regulatory operations or systems management.
- Other info: Inclusive culture with great career progression and exciting company events.
The predicted salary is between 36000 - 60000 £ per year.
Competitive Salary & Company Benefits | Ideally located close to Petersfield or Leicester. Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day).
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world? Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
The Regulatory Affairs Executive, Systems and Operations is responsible for the effective management, maintenance, and optimisation of all regulatory information systems and operational processes within the organisation. This role plays a critical part in ensuring the accuracy, integrity, and accessibility of regulatory data, streamlining submissions, and enhancing overall regulatory compliance efficiency. The executive will act as a key liaison between regulatory affairs, IT, and other departments to implement, troubleshoot, and improve the digital infrastructure supporting regulatory activities.
What will you be doing?
- Regulatory Systems Management
- Administer, maintain, and support regulatory information management systems (e.g. electronic document management systems (EDMS), regulatory information management (RIM) systems, submission publishing tools, tracking databases).
- Ensure the integrity, accuracy, and completeness of regulatory data within all systems.
- Manage user access, permissions, and training for regulatory systems.
- Monitor system performance, identify issues, and collaborate with IT and vendors for resolution.
- Stay abreast of new technologies and system enhancements relevant to regulatory affairs.
- Regulatory Operations & Process Optimisation
- Develop, implement, and maintain standardised regulatory operational procedures and workflows.
- Support the compilation, publishing, and submission of regulatory dossiers (e.g. eCTD) according to agency requirements (e.g. MHRA).
- Manage and track regulatory commitments, deadlines, and submissions to ensure timely delivery.
- Identify opportunities for process improvements and automation within regulatory operations to increase efficiency and reduce risk.
- Develop and maintain regulatory submission calendars and tracking tools.
- Facilitate regulatory intelligence gathering and dissemination within the organisation.
- Data Management & Reporting
- Oversee the quality and consistency of regulatory data entry.
- Generate regular reports on submission status, regulatory commitments, and system metrics.
- Support the creation of dashboards and analytics to provide insights into regulatory performance.
- Ensure data archiving and retrieval processes comply with regulatory requirements.
- Compliance & Quality Assurance
- Ensure regulatory systems and processes comply with applicable regulations, guidelines (e.g. GxP, data integrity principles), and internal SOPs.
- Participate in internal and external audits related to regulatory systems and data.
- Support the development and maintenance of regulatory SOPs and work instructions.
- Implement and monitor change control procedures for regulatory systems and processes.
- Cross-Functional Collaboration & Training
- Act as a subject matter expert and provide training and support to regulatory affairs staff and other departments on regulatory systems and processes.
- Liaise with IT, Quality Assurance, Research & Development, and other relevant departments to ensure seamless integration of regulatory activities.
- Collaborate with external vendors and consultants for system implementation and support.
The Person
- Qualifications
- Bachelor's degree in a scientific, technical, or related field (e.g. Life Sciences, Computer Science, Regulatory Affairs).
- Experience
- Minimum of 2 years of experience in regulatory operations, regulatory systems management, or a similar role within the pharmaceutical, biotechnology, medical device, or other regulated industry.
- Proven experience with electronic regulatory submission formats (e.g. eCTD) and publishing tools.
- Hands-on experience with regulatory information management (RIM) systems (e.g., Veeva RIM, ArisGlobal, MasterControl, Lorenz docuBridge).
- Experience with document management systems (e.g. SharePoint, Documentum, OpenText).
- Technical Skills
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Strong understanding of regulatory submission requirements and lifecycles.
- Familiarity with regulatory agency portals and submission gateways.
- Knowledge of data integrity principles and GxP regulations.
- Experience with process mapping and optimisation tools is a plus.
- Soft Skills
- Excellent analytical and problem-solving skills.
- Strong attention to detail and accuracy.
- Exceptional organisational and time management abilities.
- Effective written and verbal communication skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Proactive, adaptable, and results oriented.
Why join us?
- As well as a fantastic, inclusive company culture, where employees are truly valued, and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:
- Generous pension scheme.
- Life Assurance cover and Employee Assistance Program.
- 25 days’ holiday plus Bank Holidays.
- Learning and development opportunities.
- Excellent opportunities for progression.
- Fantastic company events and celebrations throughout the year.
Regulatory Affairs Executive, Systems and Operations employer: Aspire Pharma Limited
Contact Detail:
Aspire Pharma Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive, Systems and Operations
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and values, and think about how your skills align with their goals. This will help you stand out as a candidate who truly gets what they’re about.
✨Tip Number 3
Practice common interview questions and have your own questions ready. This shows you're engaged and interested in the role. Plus, it gives you a chance to assess if the company is the right fit for you too!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Executive, Systems and Operations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Executive role. Highlight relevant experience in regulatory systems management and operations, and don’t forget to mention any specific tools you’ve used that 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 improving patients’ lives and how your skills can contribute to our mission at Aspire Pharma. Keep it concise but impactful!
Showcase Your Technical Skills: We want to see your technical prowess! Be sure to include your experience with electronic submission formats like eCTD and any regulatory information management systems you’ve worked with. This will help us see how you fit into our team.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Aspire Pharma Limited
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory submission requirements and lifecycles. Familiarise yourself with electronic submission formats like eCTD and the specific systems mentioned in the job description, such as Veeva RIM or MasterControl. This will show that you're not just interested in the role but also understand the technical aspects involved.
✨Showcase Your Problem-Solving Skills
During the interview, be ready to discuss examples of how you've tackled challenges in regulatory operations or systems management. Think about times when you identified process improvements or resolved issues with regulatory data. This will highlight your analytical skills and proactive approach, which are crucial for this role.
✨Demonstrate Cross-Functional Collaboration
Since the role involves liaising with various departments, prepare to talk about your experience working with teams outside of regulatory affairs. Share specific examples of how you've collaborated with IT, Quality Assurance, or other departments to enhance regulatory processes. This will show that you can work well in a team-oriented environment.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to regulatory compliance or how they stay updated with new technologies. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals.
