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- Tasks: Join our team as a Regulatory Affairs Consultant, managing client and company projects.
- Company: We are experts in UK and EU pharmaceutical regulatory affairs, prioritizing a positive workplace culture.
- Benefits: Enjoy flexible remote work, 6 weeks holiday, private healthcare, and a competitive salary.
- Why this job: Be part of a dynamic team that values your contributions and supports your professional growth.
- Qualifications: Life Sciences degree and 2-4 years of relevant Regulatory Affairs experience required.
- Other info: Must have a professional setting for video calls and reliable internet.
The predicted salary is between 36000 - 60000 £ per year.
*No recruiters please*
THE COMPANY
We are Regulatory Affairs experts who specialise in the UK and EU pharmaceutical industry and offer a bespoke consultancy service to our clients.
Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire talented, dedicated and passionate individuals who share these same values. We take our work-life balance seriously and offer remote and flexible working along with 6 weeks holiday each year and an attractive Vitality private healthcare plan. By prioritising this, our clients benefit from our energetic and committed team who work hard to make our clients' goals, their goals!
We continue to grow and are delighted to be recruiting for our next member of the team in the Regulatory Affairs Department.
THE ROLE
There are two aspects to this role as it is split between working on client projects and company projects:
1) Client projects
There are opportunities to utilise and grow your experience by working with our established 'big pharma' clients as well as supporting start-ups. Examples of client work includes:
- Taking responsibility for a portfolio of our clients’ products, carrying out life cycle management activities
- Joining our clients’ teams to support their regulatory needs
- Regulatory strategy and scientific advice meetings
- Running projects such as MAA submissions, de-branding, change of ownership
- Representation during internal/external audits or Health Authority inspections
2) Fusion projects
We strive for continuous improvement and with this brings activities that the whole team contributes towards, such as:
- Project management
- Blog and newsletter writing
- Hosting webinars
- Regulatory Intelligence – interpreting changes and communicating these to our community
- Business development activities such as creating marketing materials
- Representing Fusion Pharma by attending conferences and networking
THE ESSENTIAL EXPERIENCE
- Life Cycle Management activities within a UK and/or EU Affiliate
- Authoring, compilation of submissions (e.g. variations, Art 61(3), PSURs, MAAs)
- Experience with National, MR/DC and Centralised procedures
- Updates to SmPCs, PILs, labelling, mock ups and prescribing information
- Update to Regulatory tracking systems such as Documentum
- Communication with the Health Authorities
- Regulatory strategy
THE ESSENTIAL REQUIREMENTS
- Life Sciences degree
- Fluent in written and spoken English with excellent communication skills and attention to detail
- 2 to 4 years Reg Affairs experience (aligned with essential experience as described above)
- Proficient in Microsoft Office applications with the ability to learn new electronic systems
- Proven competency with working autonomously and multi-tasking in a fast-paced environment
- Committed to representing Fusion Pharma to a high standard, face to face and remotely
- Role requires an enthusiastic, motivated and driven individual
- The successful candidate will have a professional work setting for company video calls and a high-speed, reliable internet connection
THE BENEFITS
- Competitive salary
- Permanent and full time
- Flexible working hours
- Remote working
- 6 weeks holiday
- Private healthcare
- Pension
Thank you for your interest!
Regulatory Affairs Consultant employer: Fusion Pharma Limited
Contact Detail:
Fusion Pharma Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks in the UK and EU pharmaceutical industry. Understanding the nuances of life cycle management and submission processes will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with 'big pharma' or start-ups. Engaging in conversations at industry conferences or webinars can provide valuable insights and connections that may help you land the job.
✨Tip Number 3
Showcase your ability to work autonomously and manage multiple tasks effectively. Prepare examples from your previous experience where you successfully juggled various responsibilities, as this is crucial for the fast-paced environment described in the job listing.
✨Tip Number 4
Demonstrate your enthusiasm for continuous improvement and professional development. Be ready to discuss how you've contributed to team projects or initiatives in the past, as this aligns with the company's focus on collaboration and growth.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Understand the Company Culture: Before applying, take some time to understand the workplace culture at Fusion Pharma. Highlight your alignment with their values of respect, dedication, and passion in your application.
Tailor Your CV: Make sure your CV reflects your relevant experience in Regulatory Affairs, particularly focusing on life cycle management activities and your familiarity with UK and EU regulations. Use specific examples to demonstrate your skills.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention how your background aligns with the responsibilities outlined in the job description, especially your experience with client projects and regulatory strategy.
Highlight Communication Skills: Since excellent communication is essential for this role, provide examples in your application that showcase your written and verbal communication skills, particularly in a regulatory context.
How to prepare for a job interview at Fusion Pharma Limited
✨Show Your Passion for Regulatory Affairs
Make sure to express your enthusiasm for the regulatory affairs field. Share specific examples of projects you've worked on and how they align with the company's focus on client success and continuous improvement.
✨Demonstrate Your Communication Skills
Since excellent communication is key in this role, prepare to discuss how you've effectively communicated with health authorities or clients in the past. Highlight any experiences where your attention to detail made a significant impact.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in life cycle management or submissions and how you overcame them, as this will showcase your ability to work autonomously.
✨Research the Company Culture
Familiarize yourself with the company's values and workplace culture. Be ready to discuss how your personal values align with theirs, especially regarding work-life balance and teamwork, as these are important aspects of their hiring process.
