At a Glance
- Tasks: Lead regulatory and pharmacovigilance strategies while ensuring compliance and quality in submissions.
- Company: Join a leading CRO with a rich history in innovative clinical trials.
- Benefits: Enjoy competitive salary, private medical, dental, pension, and 25 days annual leave.
- Other info: Dynamic role with opportunities for growth and collaboration with top pharma companies.
- Why this job: Make a real impact in advancing next-gen therapies and shaping the future of healthcare.
- Qualifications: Degree in life sciences and strong leadership in regulatory frameworks required.
The predicted salary is between 51750 - 63250 £ per year.
Director of Regulatory & Pharmacovigilance
Job Title
Director of Regulatory & Pharmacovigilance
Location
London (4 days on-site)
Term
Permanent, Full-time
Salary
Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)
The Role
Kelaca is looking for a
Director of Regulatory & Pharmacovigilance for their client partner in London, England.
The Director of Regulatory Strategy & Pharmacovigilance is responsible for the strategic leadership, delivery, and performance of Regulatory, Pharmacovigilance, and Medical Writing activities at the company.
This role ensures the organisation delivers high-quality, compliant regulatory submissions, pharmacovigilance systems, and scientific documentation, while building and growing Pharmacovigilance as a standalone service offering, including through independent client contracts.
The postholder will lead the integrated regulatory and safety strategy, strengthen delivery capability, and ensure the company maintains its reputation for scientific excellence, quality, and reliability.
Main duties and responsibilities
- Leadership
- Be the senior expert in regulatory across early clinical development
- Chair and lead an Expert Regulatory Advisory Board, leveraging external expertise to inform strategic clinical development and regulatory decision-making.
- Provide strategic leadership across Regulatory, Pharmacovigilance, and Medical Writing
- Lead, develop, and structure teams to ensure high-quality delivery and scalability
- Establish clear accountability for outcomes, performance, and standards across all functions
- Drive capability development and operational efficiency
- Ensure strong alignment with Clinical Project Delivery, Commercial, and Quality Assurance teams
- Take full accountability for departmental performance against business objectives
- Regulatory
- Develop and execute regulatory services for client companies, including however not limited to:
- Regulatory Submissions
- Regulatory Strategy, Analysis & Development
- Knowledgeable of innovative regulatory pathways such as ILAP and provide regulatory support and access to sponsors.
- Support business development functions (i. e., provide insight on BD calls, bid defences, etc.) to secure new clients and projects.
- Provide regular updates to senior management and other appropriate teams on important regulatory/guideline changes and lead efforts to effect changes within the organisation.
- Ensure overall compliance with regulatory requirements and guidance in collaboration with the compliance team.
- Advise on the business impact of new regulatory requirements or guidance.
- Provide regulatory expertise to project teams on all aspects of the clinical trials process.
- Support the organisation and preparation of regulatory submissions, ensuring accuracy and regulatory appropriateness.
- Work closely with Clinical Project Delivery to support the maintenance of filing and tracking databases of company regulatory information (concerning current, pending and future approvals).
- Lead engagement with regulatory bodies, government agencies, and other key stakeholders to represent the interests of the company, such as during periods of consultation and stakeholder meetings.
- Medical Writing
- Oversee the preparation, and submission, of all trial documentation in accordance with regulatory requirements.
- Ensure factual accuracy and regulatory compliance for all content development.
- Demonstrate an advanced understanding of core scientific principles underpinning medical writing tasks.
- Demonstrate excellent scientific writing, editing and data comprehension skills on a range of different project types, providing accurate and clear content.
- Undertake content development with input and guidance from senior management and QA.
- Support business development activities, attending bid defence meetings where required.
- Continuously update and improve processes.
- Play a key role in developing and enacting the business publication strategy. Providing significant contribution to authorship.
- Pharmacovigilance
- Hold full accountability for the Pharmacovigilance function, including systems, compliance, and delivery
- Oversee all safety-related activities, including safety reporting, signal detection, and risk management
- Ensure compliant setup, maintenance, and continuous improvement of Pharmacovigilance systems and databases
- Develop and implement a strategy to grow Pharmacovigilance as a service offering
- Identify and secure opportunities for independent Pharmacovigilance contracts
- Pro-actively support Business Development in positioning Pharmacovigilance capability to clients
- Ensure delivery models support both compliance and profitability
- Track and report on Pharmacovigilance performance, including revenue and delivery metrics
- Organisation and Planning
- Ensure effective planning, tracking, and reporting across Regulatory, PV, and Medical Writing
- Identify and manage risks across delivery, compliance, and scope
- Drive continuous process improvement and operational efficiency
- Build resilient and scalable functions with appropriate succession planning
- Resource and Budget Management
- Own resource planning, forecasting, and utilisation across all functions
- Align resource allocation with organisational priorities and Pharmacovigilance growth
- Establish and track KPIs across delivery, quality, and performance
- Collaboration and Relationships
- The main contact for regulatory matters and interface with internal and external teams.
- Build strong sponsor relationships and act as a trusted advisor
- Develop relationships with external experts, regulatory bodies, and suppliers
- Establish and maintain excellent working relationships within and across departments.
- Effective organisation and prioritisation of medical writing/regulatory workload.
Qualifications and Experience
- Educated to degree level in a relevant scientific, medical or life sciences subject
- Strong leadership and strategic planning, including successfully coaching and mentoring multi-disciplined teams
- Deep expertise in regulatory frameworks and pharmacovigilance
- Proven ability in the writing of key regulatory documentation, including Clinical Trial Applications (CTAs), Investigational New Drug Applications (INDs), and Scientific Advice requests
- Strong understanding of clinical trial design and early phase development
- Ability to apply scientific and regulatory knowledge to operational delivery
- Active GMC license (Desirable)
About the Company
A rich 25-year history as a leading Contract Research Organisation (CRO) with a heritage in first- in- human and adaptive clinical trials.
It has conducted around 20% of all UK Phase 1 studies and ran the first clinical trial in which CRISPR therapy was delivered through the bloodstream to edit genes inside the human body.
Today, the company supports global pharmaceutical, biotech, and genetic engineering partners, including several top 10 pharma companies, in advancing next- generation therapies.
More recently, it established the an Institute to expand understanding of under- researched diseases.
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Director of Regulatory & Pharmacovigilance employer: Kelaca
Kelaca is an exceptional employer that fosters a dynamic and innovative work culture in the heart of London. With a strong emphasis on employee growth, you will have the opportunity to engage directly with clients from the outset, translating AI capabilities into impactful business solutions. The collaborative environment encourages independent thinking and offers unique advantages such as access to cutting-edge technology and a commitment to driving meaningful outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Director of Regulatory & Pharmacovigilance
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Kelaca. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Kelaca.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Kelaca. 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 Kelaca is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director of Regulatory & Pharmacovigilance
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 Kelaca!
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 Kelaca 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 Kelaca!
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 Kelaca, 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 Kelaca
✨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 Kelaca 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 Kelaca’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.
