At a Glance
- Tasks: Lead regulatory strategy for oncology and neurology products, ensuring timely approvals.
- Company: Established pharmaceutical company focused on innovative oncology and neurology solutions.
- Benefits: Competitive salary, bonus, car allowance, life assurance, pension, and private healthcare.
- Other info: Hybrid work model with opportunities for career growth in a dynamic environment.
- Why this job: Make a real impact in global health by guiding drug approvals and product development.
- Qualifications: Extensive experience in Regulatory Affairs within biotech or biopharmaceutical industries.
The predicted salary is between 63000 - 77000 £ per year.
An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy. Directing the development of submissions of Oncology or Neurology clinical trial applications, product registration dossiers, supplements, and amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organisation.
Responsibilities:
- Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
- Interact and negotiate with regulatory agency personnel in order to expedite approval of pending registration and answer any questions.
- Serves as a regulatory liaison on the project team throughout the product lifecycle.
- Ensures that clinical trial designs meet regulatory requirements.
- Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical devices and continued approved status of marketed drugs.
- Serves as regulatory representative to the project team, developing regulatory strategy for assets.
- Advice on all aspects of product development from a regulatory perspective.
Requirements:
- Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
- Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA.
- Experience in Clinical Trial Applications, including submission and maintenance PIPS (Paediatric Investigation Plan) experience preferred but not required.
- Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.
An excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with some excellent benefits, including a bonus, car allowance, life assurance, pension scheme, and private healthcare. This role does not provide sponsorship, and you must have the Right to Work in the UK.
Associate Director, Global Regulatory Affairs Strategy employer: Cpl
As a Salesforce Technical Performance Developer, you will thrive in a dynamic and innovative work environment that prioritises employee growth and collaboration. Our company offers competitive benefits, a strong focus on professional development, and a culture that encourages creativity and problem-solving. Located in a vibrant area, we provide unique opportunities to work on complex projects while enjoying a supportive atmosphere that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Global Regulatory Affairs Strategy
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Cpl. 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.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Cpl. 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 is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director, Global Regulatory Affairs Strategy
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!
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 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!
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, 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
✨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 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’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.
