At a Glance
- Tasks: Lead EU regulatory submissions and liaise with regulators from the comfort of your home.
- Company: Join Theradex Systems, a leader in regulatory affairs with a global impact.
- Benefits: Flexible remote work, competitive pay, and a chance to shape regulatory strategies.
- Other info: 6-month contract with potential for growth in a dynamic environment.
- Why this job: Make a difference in the regulatory landscape while working on exciting projects.
- Qualifications: Extensive EU regulatory experience and knowledge of ICH-GCP required.
The predicted salary is between 63000 - 77000 £ per year.
Theradex Systems, Inc. in the UK/Europe is seeking a Contract Regulatory Affairs Manager/Senior Manager to lead EU regulatory submissions, incl.
CTA and amendments, and to liaise with EU regulators.
This is a 6-month T&M contract, remote option available for based in the UK or Sweden.
The role requires substantial EU regulatory experience, knowledge of ICH-GCP, DSURs, USMs, and input into regulatory strategies.
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Remote EU Regulatory Affairs Senior Manager (CTA/Submissions) employer: Theradex Systems, Inc.
Theradex Systems, Inc. is an excellent employer for those seeking a meaningful career in clinical data management, particularly within the dynamic field of oncology. With a hybrid work model that promotes flexibility and a supportive culture focused on collaboration and compliance, employees benefit from competitive compensation, pension contributions, and private medical insurance. The company also prioritises professional growth, offering opportunities to lead impactful studies while working in a vibrant location like Crawley, West Sussex.
StudySmarter Expert Advice🤫
We think this is how you could land Remote EU Regulatory Affairs Senior Manager (CTA/Submissions)
✨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 Theradex Systems, Inc..
We think you need these skills to ace Remote EU Regulatory Affairs Senior Manager (CTA/Submissions)
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 Theradex Systems, Inc..
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 Theradex Systems, Inc.. 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 Theradex Systems, Inc.
✨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 Theradex Systems, Inc..
✨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 Theradex Systems, Inc. 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.
