About the job Summary

Would you like to be part of a vibrant group focused on the development and assessment of medical countermeasures which will keep our Armed Forces safe?

Can you help make a difference to the UK's safety and security by applying your regulatory and scientific knowledge in this critical area? Are you keen to seek new challenges and work collaboratively with colleagues and partners across the world to deliver solutions?

The work of the Toxicology, Trauma and Medicine Group within the Chemical, Biological and Radiological (CBR) Division is aimed at understanding and mitigating the lethal and incapacitating effects of various chemical and biological insults on the human body. Suitable medical countermeasures (small molecule drugs or biologicals) are identified within the research space, with successful candidate products taken forward into the Advanced Development Programme (ADP) to work towards a MAA. Candidate pharmaceutical products which progress to the Advanced Development Programme  are rigorously tested to ensure they meet the quality, safety and efficacy standards required for licensure by the regulatory authorities.

The research and development outcomes may inform a range of strategic and policy decisions across MOD and wider government.

We are seeking a Pharmaceutical Regulatory Affairs Specialist to join the Advanced Development Programme (ADP) team. You will join a small, busy, multi-disciplinary team comprising of subject matter experts, to deliver safe and efficacious medical countermeasure products licensed by the regulatory authorities. The primary focus for the successful candidate will be a range of regulatory activities across the lifecycle of the Dstl pharmaceutical product portfolio, which includes a diverse range of products in development.

Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution.

We particularly welcome female and ethnic minority applicants and those from the LGBTQI community, as they are under-represented within Dstl at these levels.

Job description

In this role you will:

• Prepare and drive regulatory development plans for each product to ensure seamless transition between development phases
• Prepare/contribute to TPPs, IBs and IMPDs
• Prepare/manage CTAs and related supporting activities
• Ensure robust regulatory plans are established and followed in order to support future pharmaceutical licensing applications
• Work collaboratively across interdisciplinary teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately
• Provide robust and reliable regulatory advice to MOD stakeholders to enable informed decision making
• Exercise good judgement to reach evidence-based decisions and be confident and clear in presenting your ideas and work to a variety of technical and non-technical audiences
• Develop regulatory documentation and make timely submissions to regulatory authorities
• Support the production of marketing authorisation applications (externally delivered)
• Manage and conduct interactions with external regulatory authorities and ensure positive and trusted relationships are developed. Assist in building electronic document structures to aid future electronic CTD compilation
• Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities at Dstl
• Promote and raise the importance of regulatory affairs issues within the organisation and amongst stakeholders
• Maintain and communicate regulatory intelligence.
• Work effectively in a team
• Organise your time and be able to prioritise activities across a number of diverse activities
• Work safely in accordance with Dstl policies and procedures

Responsibilities

We are looking for an individual who has a significant level of experience applying expert regulatory knowledge to the pharmaceutical development lifecycle to join the ADP team. You will have prior experience in applying regulatory legislation and will have had previous interactions with the regulatory authorities, especially the MHRA. The successful candidate will work across teams, scientists and project managers to enable delivery of the projects.

Your responsibilities will include driving the regulatory requirements, decisions and actions, in support of marketing authorisation applications (MAAs) for medical countermeasures. You will be required to engage at all levels within the organisation and externally with the MOD and other organisations, including regulatory authorities.

You will have:

• Extensive experience of applying expert regulatory knowledge to the pharmaceutical development lifecycle
• Experience in a pharmaceutical company or CRO
• A good working knowledge of all current regulatory guidelines and regulations
• Strong understanding of CMC requirements
• Experience of constructing regulatory plans/strategies for pharmaceutical development projects
• Experience of contributing to/preparing Target Product Profiles (TPPs), Investigator’s Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs)
• Experience of preparing/managing Clinical Trial Applications (CTAs)
• Experience of interacting with regulatory authorities
• At least 3 years of regulatory affairs experience in pharmaceutical development
• A proven track record of working collaboratively within teams
• The ability to organise, plan and implement projects to deadlines
• Strong written and verbal communication skills
• A commitment to undertake continuing professional development throughout their career.

Essential Skills and Experience

• You will have extensive experience of regulatory affairs experience in pharmaceutical development (pharmaceutical company or CRO)
• You will have a good working knowledge of current regulatory guidelines and regulations
• You will have a good working knowledge of the pharmaceutical development lifecycle
• You will have good working knowledge of the clinical trials regulations
• You will have demonstrable experience of contributing to/preparing TPPs, IBs and IMPDs
• You will have demonstrable experience of preparing and/or managing CTAs
• You will have demonstrable experience of interactions with regulatory authorities
• You will have the ability to work methodically with good attention to detail
• You will have good IT skills.

Leadership

As a leader in Defence you will help shape, role model and bring to life the ‘One Defence’ mindset that will enable us to deliver our vision and strategic objectives. Your leadership style must be inspiring, confident and empowering. Working at every level of our organisation to break down silos, unite teams and create a culture that is trusting, collaborative, innovative, diverse and inclusive. Enabling us to deliver with pace and agility through the skills, commitment and empowerment of our employees and military colleagues.

Important Information

Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners.

This role will require full UK security clearance and you should have resided in the UK for the past 5 years. For some roles Developed Vetting will also be required, in this case you should have resided in the UK for the past 10 years.

Behaviours

We'll assess you against these behaviours during the selection process:

• Making Effective Decisions
• Working Together
• Delivering at Pace
• Leadership