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)

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.

• 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

• 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.

• 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…