At a Glance
- Tasks: Lead global regulatory strategies and drive submissions for innovative pharmaceutical products.
- Company: Join a leading global pharmaceutical company focused on Oncology and Neurology.
- Benefits: Competitive salary, bonus, car allowance, private healthcare, pension, and life assurance.
- Other info: Hybrid work model with a strategic role in a dynamic industry.
- Why this job: Shape the future of healthcare by influencing global regulatory strategies and approvals.
- Qualifications: Bachelor's degree in a scientific field and significant Regulatory Affairs experience.
The predicted salary is between 63000 - 77000 £ per year.
An exciting opportunity has arisen for an experienced Regulatory Affairs leader to join a global pharmaceutical company with a strong presence in Oncology and Neurology. This strategic role will lead the development and execution of global regulatory strategies, driving assets from early development through to approval and lifecycle management.
As the Regulatory lead, you will play a key role in shaping end-to-end regulatory strategy, leading interactions with global health authorities, supporting major submissions, and driving successful outcomes for Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), and lifecycle activities. Experience with Paediatric Investigation Plans (PIPs) will be highly advantageous.
Key Responsibilities- Lead and execute global regulatory strategies across Neurology programmes.
- Provide strategic regulatory leadership to cross-functional project teams throughout the product lifecycle.
- Act as the primary regulatory contact for global health authorities, including the EMA and other international agencies.
- Drive and oversee major submissions, including MAAs, CTAs, variations, supplements, and amendments.
- Lead regulatory aspects of PIP development, submission, and negotiation where applicable.
- Develop regulatory pathways and agency engagement strategies to accelerate approvals and minimise development risk.
- Ensure clinical development plans and trial designs meet evolving global regulatory requirements.
- Provide expert guidance on regulatory requirements, product development, and registration strategies.
- Bachelor's degree in a relevant scientific discipline.
- Significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Proven track record of developing and leading global regulatory strategies for innovative products.
- Extensive experience leading MAA submissions and Health Authority interactions, particularly with the EMA.
- Experience with Clinical Trial Applications (CTAs) and regulatory maintenance activities.
- Knowledge of Paediatric Investigation Plans (PIPs) is highly desirable.
- Strong understanding of global regulatory frameworks governing pharmaceutical development and registration.
This is an excellent opportunity for a senior regulatory professional seeking a highly visible strategic position with significant influence on global development and registration activities. Sponsorship is not available, and applicants must have the right to work in the UK.
Director of Regulatory Affairs employer: Cpl Life Sciences
Cpl Life Sciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the vibrant streaming and entertainment sector. Employees benefit from immediate project impact opportunities, comprehensive training, and career growth in a cloud-oriented environment, making it an ideal place for those looking to advance their skills in data engineering while working with cutting-edge technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Director of Regulatory Affairs
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Cpl Life Sciences. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Cpl Life Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Cpl Life Sciences. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Cpl Life Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Cpl Life Sciences!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Cpl Life Sciences that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Cpl Life Sciences!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Cpl Life Sciences, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Cpl Life Sciences
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Cpl Life Sciences that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Cpl Life Sciences’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
