Pharmaceutical Regulatory Affairs Specialist *Re-opened*

Pharmaceutical Regulatory Affairs Specialist *Re-opened* 150 150 tcl-admin
Pharmaceutical Regulatory Affairs Specialist *Re-opened*
Contract / Temporary

PSR 1JP00067843

Posted: 13th March 2023 16:01
Apply Related Jobs
  • 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

  • Salisbury
What's involved with this role:

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:

  1. 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
  2. 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.
  3. Your availability to work either immediately, or at short notice.
  4. 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:

  1. Any local authority/public sector experience
  2. 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.



Please note that clients invariably ask us to strip out contact details from CVs before we submit them for consideration. This is always quicker and easier to do if you send your CV to us in Word format, rather than as a PDF please

Give yourself the best chance of success - View our CV Tip

Submit Your Application

Thank you for your interested in this job. Please use the form below to apply.

Please note we do not accept applications without a CV.
If you do not have a CV available right now, please click the "No CV?" button above and we will email you a reminder to add your CV to, when you can.

Drop files here browse files ...
If you would prefer to send a CV straight to us rather than by way of an on-line application, you are very welcome to do so via [email protected] but please quote both the job reference and job title exactly as they appear below:
Job Ref: PSR 1JP00067843
Pharmaceutical Regulatory Affairs Specialist *Re-opened*
Client Category: Central Government Ministry

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.

Please do try to resist contacting us with requests for progress updates.

We really do read every CV sent to us. All applications will be acknowledged by a human, not a robot, provided the job remains live and provided your CV meets the “Essential Requirements” listed.

Please note that we do our level best to take down ads as soon as roles have been filled. We are not in the business of harvesting CVs.

Important: We will interpret your application as being permission to submit your CV to this role (with the right to represent you) unless you advise us to the contrary.

Email Job Reminder

If you do not have a CV available right now please use this form to send yourself a reminder. When your CV is available, simply click the link in the email or alternatively reply to that email with your attached your CV.

Job Ref: PSR 1JP00067843
Pharmaceutical Regulatory Affairs Specialist *Re-opened*
Client Category: Central Government Ministry

CV Tips

Your CV needs to be current with your most recent role. We won’t be able to submit it with any unexplained gaps in employment. It will save time and improve your chances of success if we can put your CV forward immediately without having to ask for revisions.

Your CV must cover the “Essential Requirements” of the role. Ideally you will address the “Essential Requirements” on each job description page directly, in a bullet point list. Please include any DBS details and other qualifications called for.

Your CV should clearly state that you are available to start work either immediately, or at short notice. In general, our clients are unable to work with notice periods of more than 1 week from the point at which a role is offered, 2 weeks at the very most.

We do not put forward covering letters, so please ensure that your CV in contains all relevant information being called for.

We recommend that you consider sending us a CV suitably tailored CV for each role that you apply for. Job board aggregator sites will generally store only one version of your CV, which can be a bit limiting, so this is to your advantage.

    New Search

    Are you sure you want to delete this file?