At a Glance
- Tasks: Drive regulatory strategy and ensure compliance for innovative pharmaceutical products.
- Company: AstraZeneca, a leader in the pharmaceutical industry with a commitment to inclusivity.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Join a dynamic team focused on innovation and patient care.
- Why this job: Make a real impact in healthcare by ensuring safe and effective treatments reach patients.
- Qualifications: Life Sciences degree and 4+ years in Regulatory Affairs within pharma.
The predicted salary is between 55000 - 65000 £ per year.
Deliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities, including project leadership. Achieve timely delivery of clinical trial approvals and maintain high regulatory compliance standards for the UK through provision of local regulatory expertise. Support the development of AstraZeneca investigational and in‑licensed/co‑development products through valued contributions to cross‑functional projects, study feasibility questionnaires, scientific advice meetings, and other related activities. Ensure full compliance with GRP requirements in line with the local Quality Management System (QMS) SOP and all other AstraZeneca policies and standards.
Accountabilities:
- Generate Competitive Licences (0-40%)
- Regulatory Compliance & Governance (0-10%)
- Commercial Support (0-15%)
- Formulate and Influence Regulatory Strategy (0-15%)
- Lead the Organisation and Improve productivity (0-10%)
- Clinical Support (0-10%)
Essential Skills/Experience:
- Life Sciences Degree or appropriate professional qualifications
- 4+ years experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company
- Post-Brexit UK Regulatory experience
- Business Relationship Management and ability to navigate and coordinate cross‑functional interactions
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Demonstrable negotiation skills
- Ability to make optimal use of IT systems
- Use of external regulatory environment and scientific knowledge skills to build a productive, positive and trustworthy relationship with local health authorities to drive meaningful interactions to the benefit of patients
- Lifecycle maintenance of UK Regulatory licences, including different types of submissions including but not limited to CMC, Labelling, etc.
- Optimisation and continuous improvement of submissions throughout the product lifecycle, applying global quality standards and timelines
- Development of regulatory strategy aligned with the disease area strategy/target product profiles, providing sustainable competitive advantage in alignment with product development and commercialisation strategies
- Application of the knowledge of changing regulatory environments to ensure compliance, minimise risk and create business opportunities
- Application of Drug Development Knowledge
- Audit and Inspection Knowledge
Desirable Skills/Experience:
- Therapy area expertise in Oncology
- Experience with clinical trial applications (CTA) and trial maintenance activities
- Experience in creating and delivering regulatory strategies for Marketing Authorisation Applications and New Indications
- Experience working in Veeva systems
- Management of reaction to change & remaining effective in new work situations & times of uncertainty; Assessment of, planning for & managing the impact on stakeholders arising from changes & applying change management techniques to appropriately engage stakeholders
- A robust understanding of the disease and therapeutic area including the regulatory and health technology assessment environment in the major markets, competitor landscape, and predictable barriers/obstacles in development
Regulatory Affairs Manager in London employer: AstraZeneca GmbH
AstraZeneca is an exceptional employer located in the vibrant Pancras Square, London, offering a dynamic work culture that fosters innovation and collaboration. With a strong commitment to employee growth, we provide ample opportunities for professional development and cross-functional engagement, ensuring that our team members can thrive in their careers while contributing to meaningful projects that impact patient lives. Our inclusive environment prioritises diversity and well-being, making AstraZeneca a rewarding place to work for those passionate about advancing healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in London
✨Unlock Networking Opportunities
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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 AstraZeneca GmbH.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like AstraZeneca GmbH. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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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 AstraZeneca GmbH is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Manager in London
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 AstraZeneca GmbH!
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 AstraZeneca GmbH 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 AstraZeneca GmbH!
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 AstraZeneca GmbH, 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 AstraZeneca GmbH
✨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 AstraZeneca GmbH 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 AstraZeneca GmbH’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.
