Director of Regulatory & Pharmacovigilance

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.