At a Glance
- Tasks: Lead global regulatory strategies for innovative renal therapy programs.
- Company: Vertex, a pioneering biotechnology company focused on transformative medicines.
- Benefits: Hybrid work options, competitive salary, and a commitment to diversity and inclusion.
- Other info: Join a top-rated workplace with excellent career growth opportunities.
- Why this job: Make a real impact in patients' lives through cutting-edge science and collaboration.
- Qualifications: Advanced degree preferred; significant regulatory affairs experience required.
The predicted salary is between 80000 - 100000 £ per year.
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.
Key Responsibilities
- 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.
- Support lifecycle management activities, including new indications, formulation changes, manufacturing updates.
- Monitor evolving global regulations, guidance, and competitive developments relevant to renal and nephrology programs.
- 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.
Knowledge and Skills
- Deep understanding of global regulatory requirements and drug development processes across major markets.
- Demonstrated ability to develop and communicate clear, actionable regulatory strategy.
- Strong leadership and influencing skills in a matrixed, cross-functional environment.
- 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.
- Strong organizational skills and ability to manage multiple priorities with attention to detail.
- Sound judgment, agility, and a proactive, solution-oriented mindset.
Education and Experience
- 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.
- Experience with renal, nephrology, rare disease, or specialty therapeutic areas preferred.
- 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.
Regulatory Strategy Director, Renal in London employer: Vertex Pharmaceuticals
Vertex is an exceptional employer, offering a dynamic work environment in Paddington, where innovation meets collaboration. Employees benefit from a strong commitment to professional growth, a hybrid work model that promotes work-life balance, and a culture that values diversity and inclusion. With a focus on developing transformative medicines for serious diseases, Vertex empowers its team members to make a meaningful impact while enjoying recognition as one of the industry's top workplaces.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Strategy Director, Renal in London
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We think you need these skills to ace Regulatory Strategy Director, Renal 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 Vertex Pharmaceuticals!
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 Vertex Pharmaceuticals 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 Vertex Pharmaceuticals!
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 Vertex Pharmaceuticals, 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 Vertex Pharmaceuticals
✨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 Vertex Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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 Vertex Pharmaceuticals’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.
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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.
