Pharmaceutical Regulatory Affairs Specialist

**Details**:
**Reference number**:

- 230810**Salary**:

- £40,514 - £54,683- Dependent on experience and qualifications**Grade**:

- Grade 7- Dstl Level 6**Contract type**:

- Permanent**Business area**:

- DSTL - Chemical, Biological & Radiological Division - Toxicology, Trauma and Medicine Group**Type of role**:

- Science**Working pattern**:

- Flexible working, Full-time**Number of posts**:

- 1Contents

Location

About the job

**Benefits**:
Things you need to know

Location
- Dstl Porton Down, Salisbury, Wiltshire SP4 0JQAbout 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?

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

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
- 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
- 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**:
**You will have**:

- 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, commitmen