At a Glance
- Tasks: Lead and coordinate regulatory submissions for pharmaceutical products across global markets.
- Company: Join a dynamic global regulatory operations team in the pharmaceutical industry.
- Benefits: Competitive hourly rate, collaborative environment, and exposure to international projects.
- Other info: Fast-paced role with opportunities for innovation and career growth.
- Why this job: Make a real impact on global health by ensuring compliance and improving submission processes.
- Qualifications: Experience in regulatory submissions and strong project management skills required.
The predicted salary is between 17.6 - 17.6 £ per hour.
We are seeking an experienced Hub Submission Manager to join a global regulatory operations team within a highly regulated pharmaceutical environment. This position is responsible for the operational management, coordination and delivery of regional and national regulatory submissions to health authorities, ensuring compliance with regulatory requirements and critical business timelines. The successful candidate will work across multiple markets and stakeholders, managing submission activities from planning and dossier preparation through to delivery and archival, while driving process improvements and operational excellence.
Key Responsibilities
- Lead and coordinate regulatory submission activities for assigned products, markets and regulatory procedures.
- Manage the planning, compilation, technical build and delivery of electronic and paper regulatory dossiers to health authorities worldwide.
- Partner with regulatory teams, country representatives and external stakeholders to ensure submission requirements, timelines and translation activities are effectively managed.
- Monitor submission milestones, identify risks and proactively resolve issues that could impact regulatory delivery schedules.
- Drive continuous improvement initiatives, supporting the development and implementation of more efficient submission processes and technologies.
- Act as a subject matter expert for submission processes, providing guidance, training and support to colleagues and project teams.
Skills, Experience & Qualifications
- Experience coordinating regulatory submissions within a pharmaceutical, biotechnology or life sciences environment.
- Strong project management and organisational skills, with the ability to manage multiple complex priorities simultaneously.
- Knowledge of regulatory submission requirements, dossier structures and applicable filing guidelines across regional and national markets.
- Experience with electronic submission systems, document management platforms and regulatory technologies.
- Bachelor's degree in Pharmacy, Life Sciences, Business, Information Technology or a related discipline, or equivalent professional experience.
- Excellent communication and stakeholder management skills, with the ability to work effectively across global teams and multicultural environments.
What's on Offer
- Opportunity to work within a global regulatory operations function supporting international product submissions.
- Exposure to a wide range of markets, regulatory procedures and health authority interactions.
- Collaborative environment with opportunities to contribute to process improvement and innovation.
- Involvement in business-critical projects supporting the development and maintenance of pharmaceutical products.
If you thrive in a fast-paced regulatory environment and have a passion for delivering high-quality submissions on a global scale, we would love to hear from you.
Hub Submission Manager - Regulatory in Sandwich employer: Lorien Careers
Join a leading pharmaceutical company that values innovation and flexibility, offering a dynamic work culture where your contributions directly impact global health outcomes. With opportunities for professional growth and the ability to work remotely from Maidenhead, you will collaborate with a talented team on diverse projects across various therapy areas, ensuring a rewarding and meaningful experience in health economics modelling.
StudySmarter Expert Advice🤫
We think this is how you could land Hub Submission Manager - Regulatory in Sandwich
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Lorien Careers.
We think you need these skills to ace Hub Submission Manager - Regulatory in Sandwich
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Lorien Careers.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Lorien Careers. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Lorien Careers
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Lorien Careers.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Lorien Careers achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
