Regulatory Affairs Advisor

Are you passionate about supporting critical defence capabilities? Do you thrive in dynamic environments where collaboration and innovation are key? If so, Defence Equipment and Support (DE&S) is seeking a Responsible Person for medicinal products to join their team, who will also be the Regulatory Affairs advisor.

You’ll become an integral member of the CBRN (Chemical, Biological, Radiological, and Nuclear) team, responsible for the procurement and support of all counter-CBRN defence capabilities. This team manages an extensive development and support program for specialised counter-CBRN medicines.

As the Responsible Person for medicinal products, you’ll ensure compliance with UK and EU regulations, safeguarding medicinal product users by implementing Good Distribution Practice (GDP). With delegated authority from the CEO, you’ll implement and maintain a robust quality management system and provide expert advice to senior MOD leadership. This role requires drive, enthusiasm, and strategic leadership to enforce policy and drive change across over 300 Defence sites worldwide. You will also ensure that DE&S operate within UK regulations, providing advice on regulatory matters, optimising flexibilities for innovative procurement.

We champion flexible ways of working. Regular in-person attendance is required to promote the benefits of face-to-face collaboration alongside flexibility of hours to support work-life balance. Initially, you may be expected to attend more frequently to familiarise yourselves with the site, the team, and your role.

What you’ll be doing

• Offer highly specialised support to the professional and operational aspects of Good Distribution Practice (GDP) across DE&S within the scope of their MOD’s Wholesale Distribution Authorisations (WDA) and Home Office controlled Drugs licences
• Support medicinal product users across Defence by mitigating potential hazards arising from poor handling, distribution and storage of medicinal products
• Ensure that a quality management system is implemented and maintained in line with UK & EU legislation/guidelines on GDP and other medical licences
• Operate primarily within the Counter- CBRN capability area but with regulatory reach across DE&S, providing governance and assurance in accordance with GDP. This is to support the other RP within Logistics, Services and Commodities domain with specific responsibilities
• Conduct routine supplier qualification, self-inspections, GDP training, SOP reviews, recall management and risk assessments
• Provide advice in areas such as regulatory affairs, requirements setting, compliance assessment, and the provision of independent advice to assist the CBRN team’s development programme
• Lead on complex issues at a strategic level, including preparing for and hosting GDP inspections, producing and enforcing policy, engagement with MOD’s senior leadership

Person specification

To be successful with your application, you'll need to show that you meet the following essential criteria:

• Hold prior relevant knowledge and experience related to the distribution of medicinal products
• Registered with a professional body (such as the General Pharmaceutical Council) and able to access their pharmaceutical knowledge and advice when it is required
• Experience of providing quality management and assurance, risk management and audit activities in a large complex organisation
• Hold a minimum of RQF Level 6 Pharmacist qualification (or equivalent), alternatively hold a minimum RQF Level 4 qualification (in any Science, Technology, Engineering and/or Maths subject) with extensive practical and managerial experience of medicinal products in a large organisation

In addition to the responsibilities above, the following technical competences and behaviours will be assessed at interview:

• ECF 05 - Quality - Expert Level
• OHSE - Audit and Assurance - Expert Level
• Communicating and Influencing - CSBC 4
• Changing and Improving - CSBC 4

Benefits

• 25 days’ annual leave +1 day a year up to 30 days, 8 bank holidays and a day off for the King’s birthday
• Flexible and hybrid working options
• Market-leading average employer pension contribution of 28.97%
• Annual performance-based bonus and recognition awards
• Access to specialist training and funded qualifications
• Support for progression
• Huge range of discounts
• Volunteering days
• Enhanced parental leave schemes

Improving innovation and enriching our culture, diversity of thought is vital to our success. So whether you’re looking for a new opportunity, a next step, or a helping hand as you return from a career break, bring your experiences and help deliver for the defence of tomorrow. Here you’ll find a supportive, family-friendly organisation to be a part of - and if you need any assistance with your application, just let us know.