Pharmaceutical Regulatory Affairs Specialist – Central Government

Government
January 9, 2024

Job Description


Job title: Pharmaceutical Regulatory Affairs Specialist – Central Government

Company: Spinwell Global

Job description: About The Role

Role: Pharmaceutical Regulatory Affairs Specialist REF 74489
Contract Length: 24 months 7.4 hours a week- this can be split across the week
Location: Hybrid – predominantly remote with the expectation to attend regulatory meetings at Salisbury and London (these are planned months in advance and are quite rare)
IR35: Inside
Pay Rate to Intermediary: Market Rate
Security Clearance: SC requested

Spinwell is recruiting for a Pharmaceutical Regulatory Affairs Specialist for an excellent opportunity within the public sector.

RESPONSIBILITIES OF THE PHARMACEUTICAL REGULATORY AFFAIRS SPECIALIST

  • Preparing and driving regulatory drug development plans for each product to ensure seamless transition between development phases to meet UK regulatory requirements.
  • 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, primarily the MHRA.
  • Supporting preparation of documents such as Target Product Profiles (TPPs), Investigator’s Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs)
  • Managing Clinical Trial Applications (CTAs) and related 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

SKILLS/EXPERIENCE OF THE PHARMACEUTICAL REGULATORY AFFAIRS SPECIALIST

  • Demonstrable experience of regulatory affairs experience in drug development (pharmaceutical company or CRO)
  • A good working knowledge of current UK regulatory guidelines and regulations
  • A good working knowledge of the drug development lifecycle
  • A good working knowledge of GCP
  • Demonstrable experience of contributing to the preparation of TPPs, IBs and IMPDs
  • Demonstrable experience of managing CTAs
  • Demonstrable experience of interactions with regulatory authorities
  • Can demonstrate maintenance of currency in regulations and requirements affecting pharmaceutical product development activities

If you are a Pharmaceutical Regulatory Affairs Specialist, apply now or send your CV to Spinwell!

We welcome all applications regardless of background, in line with our commitment to diversity, equality and inclusion.
Applying to this or any other vacancy advertised by Spinwell Ltd constitutes an agreement for Spinwell Ltd to hold your details for 24 months for the purpose of assessing suitability for the advertised position and to make you aware of any other positions deemed suitable of which You will make you aware by means of either email, text or phone. In line with GDPR regulations you are able to request your details be removed from the company data at any time by emailing us

Expected salary:

Location: Salisbury – London

Job date: Sun, 07 Jan 2024 03:46:08 GMT

Apply for the job now!

Location

Related Jobs