CV-Library
Regulatory Affairs Manager
Cure Talent are delighted to be partnered with a global CDMO specialising in complex drug-device combination products, as they continue to expand their Regulatory Affairs capability following a period of significant growth.
As part of an ongoing reorganisation, the business is growing its regulatory team and appointing Regulatory Manager to lead project delivery across a diverse portfolio of combination products, with a strong focus on inhalation and respiratory devices. This is a client-facing, hands-on leadership role where you will be responsible for driving regulatory strategy and delivery across multiple projects, acting as the regulatory subject matter expert and primary point of contact for customers and regulatory agencies.
As the Regulatory Manager, you will lead the regulatory aspects of development programmes, contributing to project planning, advising on regulatory pathways and ensuring high-quality submission content, with particular focus on Module 3 authoring. You will work closely with internal teams and external clients, providing clear, confident regulatory guidance and challenging where required to ensure compliant and efficient routes to market.
This role combines leadership with delivery. While you will have responsibility for mentoring and developing team members, this is not a role for someone who wants to step away from the detail. You will remain hands-on, owning projects and contributing directly to regulatory documentation and submissions.
To be successful as the new Regulatory Manager, you will bring proven experience authoring Module 3 documentation for drug-device combination products or inhalation / respiratory drug products. You will be confident operating in a client-facing environment, able to define and defend regulatory strategy, and comfortable taking ownership of complex programmes as the regulatory lead.
Key Responsibilities
* Lead regulatory strategy and delivery for drug-device combination development programmes.
* Author and review regulatory documentation, with direct ownership of Module 3 content.
* Act as the primary regulatory contact for clients and external regulatory agencies.
* Provide regulatory input into project planning, timelines and resource requirements.
* Review and approve regulatory documentation prepared by Specialists and Associates.
* Support and mentor team members, driving performance and development.
* Contribute to regulatory intelligence and advise on evolving regulatory requirements.
* Represent the regulatory function in client meetings and internal governance forums.
Experience and Skills Required
* Proven experience authoring Module 3 documentation as part of regulatory submissions.
* Experience within drug-device combination products or inhalation / respiratory delivery systems.
* Strong understanding of global regulatory requirements for combination products.
* Experience operating in a client-facing or consultancy/CDMO environment is advantageous.
* Ability to manage multiple projects and influence stakeholders at all levels.
* Strong communication skills and confidence in presenting and challenging regulatory strategy.
This is a high-impact role within a growing organisation where Regulatory plays a central role in client delivery and product development. It will suit someone who is comfortable in the detail, confident in front of clients and capable of leading regulatory workstreams end-to-end
£65000 – £80000/annum Bonus, Pension, Private Healthcare