- Pay Rate:
Up to £594.94 per day pay range subject to IR35 status
- Hours per Week:
22 hours per week / part time – 3 days per week at 7.4 hours per day (can consider flexibility)
Anticipated 24 months
Interim Pharmaceutical Regulatory Affairs Specialist -Part-time – PSR 1JP00067843 *Re-opened*
Pay Rate: Up to £594.94 per day pay range subject to IR35 status
Location: Salisbury – Flexible working available – to begin with you will be in at least one day a week and then from then on it will be work delivery dependent.
You may need to attend London for a meeting but this would be ad hoc and with notice (expenses may be provided for any travel to sites / locations outside of job location).
Contract Length: Anticipated 2 years / 22 hours per week / part time – 3 days per week at 7.4 hours per day (can consider flexibility)
Existing security clearance is not a prerequisite but will always help.
The Pharmaceutical Regulatory Affairs Specialist is needed to join a small, busy, multifunctional team of pharmaceutical development staff and Project Managers. The role has responsibility for a number of regulatory activities, across the lifecycle of the organisational pharmaceutical product portfolio, which includes diverse products from small molecules to biologicals.
The successful candidate will work closely with Project Managers and project development teams in supporting the following range of activities:
Existing security clearance is not a prerequisite but will always help
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
- Supporting the production of Marketing Authorisation applications (externally delivered)
- 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
- 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
Please quote the Job Title & Vacancy Reference No. in your application, or we will be unable to match your CV to the role being applied for.
“Essential Requirements” – Please check to ensure that your CV addresses the following items:
- Our clients are generally seeking applicants who are reasonably local, not that they would exclude candidates willing to travel/relocate, so on that basis we would ideally like you to supply us with your address (or at least your post code) and a telephone number so that we can reach you during working hours
- 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
NB: Please feel free to apply to us direct via [email protected] by quoting the job reference and job title exactly. SEE DETAILS AT THE BOTTOM OF THIS AD.
If you have previously applied to one of our vacancies and have already sent the required supporting documentation to us, please make this clear when you re-apply as this will help speed up your application.
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Pharmaceutical Regulatory Affairs Specialist *Re-opened*
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