Senior Manager / Associate Director, Regulatory Affairs

Location: Farnborough, 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

Specialist CRO and EU/UK MAH providing integrated pharma/biotech services and full RA support across multiple geographies.
The organisation manages development and post-approval activities as MAH, including MAA, MA maintenance, PV and GMP-related obligations in the UK, EU and global markets.

Role summary

The Senior Manager / Associate Director, Regulatory Services provides RA support and leadership on multi-geography projects, translating complex client requirements into clear RA strategies and tangible actions.
The role combines hands-on MAA and lifecycle execution (including MAH activities) with CTD authoring/QC, project leadership, BD support and mentoring of more junior RA colleagues.

Key responsibilities

Leadership and people

• Act as an ambassador for the company and its CRO/MAH offering in all internal and external interactions.

• Build and maintain effective working relationships with internal RA staff and external Associates, providing ongoing feedback to ensure high-quality outputs.

• Support onboarding and development of new RA team members, offering day-to-day guidance and technical oversight where delegated.

BD, proposals and budgets

• Proactively spot BD opportunities arising during project delivery and flag them into senior RA/BD discussions.

• Provide RA input into scopes, proposals and budgets for small, medium and large projects (e.g. CTAs, MAAs, variations, MA transfers, MAH services).

• Attend client visits, conferences and exhibitions as required to support BD and positioning of RA/MAH capabilities.

Project management

• Take overall accountability for assigned RA projects, ensuring deliverables are on time, on budget and in scope while maintaining quality and client satisfaction.

• Plan, schedule and coordinate technical and management activities; lead client and internal project meetings when needed.

• Delegate project tasks (coordination, logistics, travel, document control) across the project team, maintaining oversight of critical path and risks.

• Track and report project status and financials at agreed intervals.

Regulatory responsibilities

Clinical development and global submissions

• Manage preparation and submission of CTAs and associated maintenance (substantial amendments, notifications, end-of-trial), coordinating RA workflow to obtain approvals/feedback from HAs.

• Support or lead IND/IMPD planning and compilation, ensuring alignment with future MAA strategy and CTD structure.

• Provide RA advice on storage, labelling and packaging across existing and emerging markets, working closely with supply, QA and PV.

MAA, CTD authoring and HA interactions

• Manage preparation of registration dossiers and submission of MAAs (CP/DCP/MRP/national) in line with HA requirements, including timely response to LoQs/deficiency letters.

• Liaise with licensing partners, affiliates and distributors to support MAAs in their territories and ensure alignment of strategy and documentation.

• Conduct critical review and internal QC of key technical/CTD documents (clinical, CMC, non-clinical) prior to submission.

• Act as RA point person for HA interactions for assigned products, including briefing packages, meeting strategy, advisory committee materials and responses to HA letters.

MAH and lifecycle management

• Manage routine MA maintenance activities (CP/DCP/MRP/national), including variations, renewals, line extensions and safety-related updates.

• Coordinate with distributors and local partners to ensure MA compliance, timely submissions and accurate translations.

• Ensure regulatory compliance of assigned licences with relevant national, EU and international requirements across the MAH portfolio.

• Implement regional/global RA strategy for assigned products, tracking RA metrics (safety, quality, timelines) and working closely with internal functions.

Legislation, GMP and internal contribution

• Maintain awareness of global RA and MAH legislation and assess impact on business and development programs.

• Maintain a working knowledge of EU/UK GMP and related guidelines and apply this to MAH/RA responsibilities.

• Represent RA at internal and external meetings as required, ensuring RA/MAH perspectives are clearly articulated.

General responsibilities

• Adhere to company policies, SOPs and all statutory requirements.

• Be proactive, bring ideas and contribute to continuous improvement and BD.

• Undertake training as required and attend staff/team/client meetings.

• Observe H&S procedures and travel to client sites, conferences and other locations as needed.

• Work flexibly within skill level to support changing priorities and ensure customer needs and business objectives are met.

Person specification

Essential

• Relevant degree in a life science discipline (or equivalent).

• Broad RA experience with a proven track record managing complex RA/clinical projects and contributing to or leading teams.

• Experience of MAA and MA lifecycle work (variations, renewals) in EU/UK and direct HA interaction.

• Experience with CTAs and preferably IND/IMPD.

• Strong interpersonal skills, able to work across all levels internally and with external Associates, partners and distributors.

• First-class organisational and administrative skills; high standard of written and spoken English and strong attention to detail.

• Proactive, reliable, with strong work ethic and commitment to meeting timelines without compromising quality.