At a Glance
- Tasks: Lead regulatory strategy for a late-stage medicinal product in rare diseases.
- Company: Planet Pharma, a dynamic company focused on innovative healthcare solutions.
- Benefits: Fully remote role with flexible working and competitive pay.
- Other info: 12-month maternity cover contract with immediate start.
- Why this job: Make a real difference in the lives of patients with rare diseases.
- Qualifications: Experience with MAA filings and strong collaboration skills required.
The predicted salary is between 60000 - 80000 £ per year.
Planet Pharma in Maidenhead is seeking an EU Regulatory Affairs Specialist to shape regulatory strategy for a late-stage medicinal product in a rare paediatric disease.
You’ll lead EMA interactions and oversee EU filings from early planning through submission.
The role requires hands-on experience with MAA filings, orphan drug approvals, and strong cross-functional collaboration with global teams.
This is a fully remote, 12-month maternity-cover contract with start ASAP, ideally in August.
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EU Regulatory Affairs Lead - Orphan/Rare-Disease MAA (Remote) in Maidenhead employer: Planet Pharma
At Planet Pharma, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of AI and healthcare. Our commitment to employee growth is reflected in our comprehensive training programmes and mentorship opportunities, ensuring that you can advance your career while making a meaningful impact on patient outcomes. Located in a vibrant area, we provide a competitive benefits package that supports work-life balance and promotes well-being.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Lead - Orphan/Rare-Disease MAA (Remote) in Maidenhead
✨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 Planet Pharma.
We think you need these skills to ace EU Regulatory Affairs Lead - Orphan/Rare-Disease MAA (Remote) in Maidenhead
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 Planet Pharma.
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 Planet Pharma. 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 Planet Pharma
✨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 Planet Pharma.
✨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 Planet Pharma 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.
