Regulatory Affairs Director

Location: Farmborough, Hampshire, UK (hybrid)
3 days per week on site (Monday, Tuesday, Thursday) *will require a car to get to the office - no public transport close to location*

Company overview

The hiring company is a specialist CRO and EU/UK MAH providing integrated pharma/biotech services and RA support across multiple geographies.
The business manages development and post-approval activities for client products as MAH, including MAA, MA maintenance, PV and GMP-related obligations in the UK, EU and global markets.

Role summary

The Regulatory Affairs Director provides senior RA leadership on complex, multi-geography projects, translating challenging client requirements into clear RA strategies and executable plans.
The role has dual focus: leading MAA and lifecycle activities (including MAH responsibilities) and driving high-quality authoring and critical review of CTD modules (clinical, CMC, non-clinical), while also contributing to BD, proposals and internal process improvement.

Key responsibilities

Leadership and line management

• Participate in leadership discussions and input into strategic business decisions on BD, service offering, internal policies and processes.
• Act as an ambassador for the company and its MAH capabilities with clients, authorities and partners.
• Line manage and mentor RA staff and Associates, providing technical oversight, performance feedback and development support.
• Ensure effective resourcing, coaching and QC across project teams to maintain high-quality, on-time RA deliverables.

BD, proposals and budgets

• Proactively identify BD opportunities arising from ongoing client work, particularly where MAH and end-to-end RA capabilities add value.
• Support or lead RA input into proposals, scopes and budgets for small to large, multi-country projects, including MAA, MA transfers and MAH services.
• Represent RA at conferences, client visits and presentations as required.

Project and portfolio management

• Assume overall accountability for the delivery of multiple RA projects, ensuring scope, timelines, budget and quality targets are met.
• Plan, schedule and coordinate technical and management aspects of projects, chairing client and internal project meetings where needed.
• Delegate tasks across project teams (coordination, tracking, document control, logistics), maintaining oversight of critical path activities.
• Track and report project status and financials at agreed intervals, escalating risk and proposing mitigation as required.

Regulatory responsibilities

MAA and CTD authoring

• Lead planning and execution of EU/UK MAA strategies (CP, DCP, MRP, national), including procedure selection, legal basis and overall CTD strategy.
• Lead or oversee authoring and critical review of CTD Modules 2–5 for MAA and major lifecycle submissions, including clinical, CMC and non-clinical components, ensuring consistency of the benefit-risk and quality narrative.
• Coordinate and QC Module 1 content (EU and UK), including MAH details, product information, RMP, PV system and site details.
• Manage Q&A phases, prepare responses and briefing packs and support oral explanations and other authority interactions.

Clinical development and global submissions

• Manage or oversee preparation and submission of CTAs and associated maintenance, including substantial amendments and end-of-trial notifications.
• Coordinate IND/IMPD content and alignment with future MAA strategy to avoid data gaps and ensure coherent CTD structure over time.
• Provide RA advice on storage, labelling and packaging requirements for global markets, working with supply chain, QA and PV as needed.

MAH and lifecycle management

• As part of the MAH function, ensure regulatory compliance of MAs across CP/DCP/MRP/national, including variations, renewals, line extensions and safety-driven updates.
• Manage distributors and local partners to ensure timely, compliant submissions, translations and implementation of approved changes.
• Ensure MAH obligations are met across EU/UK, including interface with PV, QA, QP, GDP and GMP-related activities and oversight of RA metrics (safety and quality).
• Maintain a working knowledge of EU/UK GMP and other relevant guidelines and ensure impact on MAH portfolio is assessed and managed.

Agency interactions and strategy

• Act as point person for HA interactions, including scientific advice, ODD, PIP, PRIME and other key procedures, and translate outcomes into product and dossier strategy.
• Prepare and lead RA sections of briefing documents, advisory committee materials, inspection support and follow-up responses.​​
• Negotiate submission data requirements, timing of deliverables and risk-based approaches with HAs and internal technical teams.

Quality, compliance and internal contribution

• Perform critical review and internal QC of key RA documents and submissions before dispatch to HAs or partners.
• Maintain awareness of global RA and MAH legislation and guidance, assess business impact and drive updates to internal SOPs, templates and best practices.
• Implement and track RA metrics related to quality, timelines and HA outcomes and feed lessons learned back into process improvements.

General responsibilities

• Adhere to all company policies, SOPs and statutory requirements.
• Contribute ideas for continuous improvement and BD, including expansion of MAH and full-service RA offerings.
• Undertake training as required and attend staff, team and client meetings.
• Travel to client sites, conferences and other locations as needed.

Person specification

Essential

• Relevant degree in a life science discipline (or equivalent).
• Broad RA experience across development and post-approval, with a proven track record managing complex RA and clinical projects and leading teams.
• Significant experience in MAA and MA lifecycle management in EU/UK, including direct HA interactions.
• Strong experience in CTD authoring/QC across clinical, CMC and non-clinical modules.
• Exceptional interpersonal skills, able to work effectively with internal teams, external Associates, distributors and clients at all levels.
• Outstanding organisational skills, high attention to detail and strong written and spoken English.
• Proactive, reliable, with a strong work ethic and consistent delivery against timelines without compromising quality.