At a Glance
- Tasks: Lead global regulatory strategies for innovative renal therapy programs and collaborate with cross-functional teams.
- Company: Vertex, a pioneering biotechnology company focused on scientific innovation.
- Benefits: Flexible hybrid work options, competitive salary, and commitment to diversity and inclusion.
- Other info: Join a dynamic team dedicated to improving lives through innovative therapies.
- Why this job: Make a real impact in patient-focused environments while navigating complex regulatory landscapes.
- Qualifications: Advanced degree preferred; significant experience in regulatory affairs within biopharmaceuticals required.
The predicted salary is between 66150 - 80850 £ per year.
General Summary: The Regulatory Affairs Director will provide global regulatory leadership for programs within the Renal Therapy Team. This role is responsible for defining and driving regulatory strategy for the International region that is aligned with global strategies to support timely advancement of investigational assets. The Director will serve as the regulatory lead on cross-functional teams and will partner closely with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, Commercial, and Program Leadership to help shape development plans and support business objectives. This individual will bring strong strategic regulatory expertise, sound judgment, and the ability to navigate complex global regulatory environments.
The role requires a collaborative leader who can influence across functions, represent Regulatory Affairs in key governance forums, and lead interactions with health authorities.
- Lead the development and execution of global regulatory strategies for renal therapy programs across all phases of development.
- Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans, evidence generation, and milestone planning.
- Drive regulatory strategy & execution for major submissions, including INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, and other post-approval filings.
- Lead planning, preparation, and execution of health authority interactions, including meeting strategy, briefing packages, agency responses, and follow-up actions.
- Provide regulatory guidance on product development, labelling strategy, expedited pathways, paediatric plans, orphan drug designations and regional registration requirements.
- Partner with Regulatory Operations and functional subject matter experts to ensure high-quality, compliant, and timely submissions.
- Assess regulatory risks and opportunities and communicate clear recommendations to team leadership and key stakeholders.
- Contribute to continuous improvement of regulatory processes, standards, and ways of working.
- Mentor and develop other regulatory team members and contribute to a strong, collaborative team culture.
Deep understanding of global regulatory requirements and drug development processes across major markets. Demonstrated ability to develop and communicate clear, actionable regulatory strategy. Experience leading complex regulatory submissions and agency interactions. Strong written and verbal communication skills, including the ability to present complex regulatory considerations to senior leadership. Advanced degree in a scientific, medical, or health-related field preferred; bachelor's degree required. Typically significant, relevant experience of regulatory affairs within the biopharmaceutical industry. Significant experience in global regulatory strategy for development-stage and/or marketed products. Prior experience with US and ex-US regulatory submissions and health authority interactions strongly preferred.
The successful candidate will be a strategic and collaborative regulatory leader who is energized by working in a science-driven, patient-focused environment. This person will be comfortable operating in a fast-paced setting, influencing without authority, and helping teams translate complex regulatory requirements into practical development strategies that support innovation and patients with serious diseases.
Location: Paddington, United Kingdom
Type: Full time
Regulatory Strategy and Planning Manager in London employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer, offering a dynamic work environment at their Milton Park R&D facility in Abingdon, where innovation thrives. Employees benefit from a strong focus on professional development, with access to training resources that foster growth in the pharmaceutical industry. The inclusive culture encourages collaboration across disciplines, making it a rewarding place for those passionate about making a meaningful impact through science.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Strategy and Planning Manager in London
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
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Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
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Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Vertex Pharmaceuticals!
We think you need these skills to ace Regulatory Strategy and Planning Manager in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Vertex Pharmaceuticals that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Vertex Pharmaceuticals.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Vertex Pharmaceuticals does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Vertex Pharmaceuticals. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Vertex Pharmaceuticals's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Vertex Pharmaceuticals. This shows your passion for the industry!
