Pharmaceutical Regulatory Affairs Specialist

2 weeks ago

Salisbury, United Kingdom Triumph Consultants Ltd Full time

**What's involved with this role**:
**Interim Pharmaceutical Regulatory Affairs Specialist -Part-time - PSR 1JP00067843**
**What you’ll do**:

- Preparing and driving regulatory development plans for each product to ensure seamless transition between development phases
- Working with technical teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately
- Managing and conducting interactions with external Regulatory Authorities
- Preparing and managing regulatory documents such as Target Product Profiles (TPPs), Investigator’s Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs) and developmental risk management plan (DRMP)
- Preparing and managing Clinical Trial Applications (CTAs) and related supporting activities
- Assisting in building electronic document structures to aid future eCTD compilation
- Maintaining regulatory intelligence and updating project teams
- Supporting and implementing regulatory aspects of organisational quality systems

**Who you are**:

- Demonstrable experience in regulatory affairs experience in pharmaceutical development (pharmaceutical company or CRO)
- A good working knowledge of current regulatory guidelines and regulations
- A good working knowledge of the pharmaceutical development lifecycle
- A good working knowledge of GCP
- Demonstrable experience of contributing to/preparing TPPs, IBs and IMPDs
- Demonstrable experience of preparing and/or managing CTAs
- Demonstrable experience of interactions with Regulatory Authorities
- Demonstrable experience of applying/constructing CTD document structures for pharmaceutical development projects to support MAAs
- Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities

**Desirable**:

- Working knowledge of GMP and GLP
- Experience of writing summary reports for regulatory submissions
- An understanding of pharmaceutical regulations in other countries/regions e.g. US FDA
- Higher qualification in a pharmaceutical related field

**“Essential Requirements” - Please check to ensure that your CV addresses the following items**:

- Your recent UK working experience going back at least 5 years, or full employment history if you have been working for fewer years than this.
- Your availability to work either immediately, or at short notice.
- Qualifications and experience relevant to the job role - please give full details within your CV document

**Other preferable/desirable details to include on your CV, if applicable**:

- Any local authority/public sector experience
- Any relevant qualifications held or being studied for

**Job Ref: PSR 1JP00067843**

**Anticipated Length of Assignment**: Unless otherwise stated (we do carry the occasional permanent vacancy) all of our roles are technically temporary, though opening assignments can be and often are, extended by clients on a longer term basis and can sometimes become permanent.

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