Quality, Regulatory & Safety Director

Job Description

About the Company

Exeltis is part of the Insud Pharma Group of biopharmaceutical organisations, with over 40 years of experience and operations in more than 50 countries. Exeltis UK was established in 2022 to bring Exeltis products to the UK market, our product portfolio spans menopause, pregnancy and sexual health, with a healthy pipeline and we are committed to finding clinical solutions to meet the unmet needs for women across key stages of their sexual and reproductive lives. This is an exciting phase in which to join Exeltis to realise their ambitions to become leaders in Women’s Health medicine and contribute to the strategy and culture that will lead to this success.

Role Purpose

The Quality, Regulatory & Safety Director provides strategic leadership and hands-on oversight of the UK affiliate’s Regulatory Affairs, Pharmacovigilance and Quality activities, with direct line management responsibility for the Quality Manager, Pharmacovigilance Manager and Regulatory Affairs Manager. The role ensures the business remains inspection ready, compliant with applicable MHRA and UK/EU requirements, and able to scale efficiently while protecting patients, maintaining product supply continuity, and enabling commercial growth. This includes ownership of a robust Pharmacovigilance system and Quality Management System consistent with MHRA GVP inspection expectations and all applicable good practice obligations.

Leadership, Strategy & Governance

• Act as the UK functional leader for Safety, Quality and Regulatory, providing strategic direction and clear priorities aligned to UK business goals.
• Lead the UK “fit-for-growth” agenda for compliance: build scalable processes, clarify decision rights, and embed consistent ways of working.
• Provide regular updates and risk assessments to the UK GM and UK Leadership Team; proactively escalate emerging compliance risks and mitigation plans. Champion a culture of quality and safety across the affiliate, ensuring compliance is understood as a business enabler and not a barrier.

Pharmacovigilance (Safety) Leadership & Oversight

• Provide oversight and governance of the UK PV system, ensuring UK obligations are met and that local PV activities align with global PV frameworks.
• Ensure robust local processes for adverse event intake, reporting, reconciliation, and timely escalation, including appropriate training and continuous improvement.
• Oversee PV Quality Management System elements relevant to the UK, including deviations, CAPAs, audits, and vendor oversight.
• Ensure PV compliance interfaces are effective across the business (e.g., Medical, Commercial, MI, Quality, Regulatory, Supply).
• Maintain inspection readiness for PV, including evidence of training, reconciliations, oversight metrics, and documented controls.

Quality Leadership (GxP / GDP / QMS)

• Oversee the UK Pharmaceutical Quality System (QMS) and ensure it is maintained, inspection-ready, and appropriate for company maturity and growth.
• Ensure effective governance of deviations, CAPA, change control, complaints, recalls, supplier qualification, audits, training compliance, and documentation.
• Provide senior oversight of Good Distribution Practice (GDP) and quality aspects of supply chain operations, including third-party logistics, wholesalers, and vendors.
• Ensure quality agreements/technical agreements are in place, maintained, and operationalised.
• Oversee Quality Management Review (QMR) with meaningful KPIs, trending, and documented actions.

Regulatory Affairs Leadership

• Oversee regulatory strategy and operational delivery for the UK portfolio (e.g., marketing authorisations, variations, renewals, labelling/SmPC/PIL maintenance)
• Ensure regulatory intelligence is captured and communicated; interpret new/updated regulatory requirements and implement changes.
• Ensure promotional and non-promotional materials meet regulatory requirements and support cross-functional approval processes.
• Maintain strong working relationships with MHRA and other relevant bodies (as appropriate), ensuring timely, high-quality interactions and responses.

Compliance, Risk Management & Inspection Readiness

• Act as the UK point of accountability for GxP compliance, ensuring clear ownership of compliance controls and rapid remediation where gaps are identified.
• Lead readiness planning and execution for MHRA inspections and internal audits across PV/Quality/Regulatory, including mock inspections where appropriate.
• Ensure effective documentation management and evidence generation aligned to regulatory expectations and internal standards.
• Oversee the maintenance of a compliance risk register for the UK affiliate; ensure risks are assessed, mitigated, and monitored.

People Leadership & Cross Functional Working

• Lead, coach and develop the Regulatory Affairs Manager, Head of Pharmacovigilance and Quality Manager; set clear objectives and support performance and development.
• Build team capability and succession plans suitable for a scaling affiliate.
• Ensure training needs analysis, role-based training compliance, and ongoing capability uplift across the affiliate (not only within the function).
• Partner with Medical, Commercial, Supply Chain, Market Access, Marketing, and Finance to embed compliant processes into day-to-day operations.
• Provide pragmatic guidance to enable speed-to-market while maintaining robust controls.
• Work closely with global teams to ensure local needs are understood, appropriately prioritised, and delivered.

Qualifications and experience

• Degree in a relevant discipline (e.g., Pharmacy, Life Sciences) or equivalent experience.
• Significant leadership experience across at least two of the following: Quality, Regulatory Affairs, Pharmacovigilance, with strong working knowledge of the third.
• Proven experience operating within a regulated UK pharma environment, including MHRA-facing responsibilities and inspection readiness.
• Demonstrated experience building/optimising systems and processes in a growing organisation (scale-up mindset).
• Strong knowledge of GxP expectations relevant to an affiliate (e.g., PV compliance, GDP/QMS, regulatory maintenance).
• Track record of managing and developing teams, with successful cross-functional influence at senior levels.

Company benefits

• Competitive salary
• Annual performance bonus
• Pension contributions
• Private medical insurance
• Income protection & life assurance
• 25 days’ annual leave, plus 3 additional days between Christmas and New Year

EXE-E/INP-CORP-2782-v1; March 2026