At a Glance
- Tasks: Support a major EU Marketing Authorisation Application for a rare disease product.
- Company: Global biotech company dedicated to transformative therapies for rare diseases.
- Benefits: 12-month contract, competitive rate, and impactful role in patient care.
- Other info: Collaborative global team with opportunities for professional growth.
- Why this job: Join at a critical stage and make a real difference for patients with rare diseases.
- Qualifications: Experience in EU MAAs, rare disease knowledge, and strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
A global biotech company focused on developing transformative therapies for patients living with rare diseases. With a major European submission on the horizon, this is an opportunity to join at a critical stage and play a hands-on role in bringing an important treatment closer to patients.
We are looking for an experienced Regulatory Affairs contractor to support a high-profile European Marketing Authorisation Application (MAA) planned for submission in 2027. This role supports the EU Regulatory Lead and takes ownership of key MAA activities. The dossier modules are being prepared, and you will work cross-functionally to drive the submission forward, coordinate stakeholders, interpret data with SMEs and support interactions with European regulators. Alongside the MAA programme, you could also support post-approval regulatory activities for another recently approved product in Europe.
Key responsibilities include:
- Supporting delivery of a major EU MAA submission for a rare disease product
- Coordinating submission activities across multiple functions
- Reviewing and interpreting data with SMEs to support regulatory documentation
- Working closely with the EU Regulatory Lead on regulatory strategy execution
- Managing deliverables and timelines across internal teams and external partners
- Supporting interactions with EMA and European regulatory requirements
- Contributing to post-approval regulatory activities on an approved programme
- Collaborating within a global regulatory team
What you will need to succeed:
- Proven experience preparing and filing EU Marketing Authorisation Applications (MAAs)
- Rare disease experience
- Orphan drug experience preferred
- Recent experience owning or leading MAA submissions
- Strong knowledge of EMA processes and European regulatory requirements
- Paediatric development experience advantageous
- Experience working with external partners and collaborations
- Strong written and verbal communication skills
- Ability to work independently in a hands-on delivery-focused role
- Collaborative approach with experience working across global, cross-functional teams
What you will get in return:
- 12-month contract
- Opportunity to play a key role in a significant European MAA submission planned for 2027
- Exposure to an innovative rare disease programme with meaningful patient impact
- Highly visible role within a global regulatory team
- Highly competitive rate
If you are interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn’t quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
EU Regulatory Affairs Snr Manager - Rare Disease MAA in Slough employer: Hays Life Sciences
Join a leading global biotech company dedicated to developing transformative therapies for patients with rare diseases, where your expertise in EU Regulatory Affairs will be pivotal in driving a major Marketing Authorisation Application. With a collaborative work culture that values innovation and meaningful patient impact, you will have the opportunity to grow professionally while contributing to life-changing treatments. This role offers a competitive rate and the chance to work within a highly visible global regulatory team at a critical juncture in the company's mission.
StudySmarter Expert Advice🤫
We think this is how you could land EU Regulatory Affairs Snr Manager - Rare Disease MAA in Slough
✨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
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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 Hays Life Sciences.
We think you need these skills to ace EU Regulatory Affairs Snr Manager - Rare Disease MAA in Slough
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 Hays Life Sciences.
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 Hays Life Sciences. 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 Hays Life Sciences
✨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 Hays Life Sciences.
✨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 Hays Life Sciences 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.
