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Pharmaceutical Regulatory Affairs Specialist/Practitioner (part-time role)

Triumph Consultants Ltd

Posted on Mar 13, 2023 by Triumph Consultants Ltd

Salisbury, Wiltshire, United Kingdom
Research
Immediate Start
Daily Salary
Contract/Project

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 life cycle of the pharmaceutical product portfolio, which includes diverse products from small molecules to biologicals.

  • Prepare and drive regulatory development plans for each product to ensure seamless transition between development phases
  • Work with technical teams to ensure robust studies are planned, carried out to the required regulatory standards and reported appropriately
  • Prepare and manage regulatory documents
  • Prepare and manage Clinical Trial Applications
  • Assist in building electronic document structures
  • Maintain regulatory intelligence and updating project teams

Key requirements:

  • Demonstrable experience in regulatory affairs experience in pharmaceutical development
  • A good working knowledge of current regulatory guidelines and regulations
  • A good working knowledge of the pharmaceutical development life cycle

Qualifications

  • Essential - Degree in a science discipline OR equivalent
  • Desirable - Higher qualification in pharmaceutical related field

Flexible working available - to begin the candidate will be expected to be in at least 1 day a week and then from then on it will be work delivery dependent. May need to attend London for a meeting but this would be ad hoc and with notice (expenses will be provided for any travel to sites/locations outside of job location)

part time role: 22 hours per week - 3 days (flexibility)

Reference: 2509885229

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Pharmaceutical Regulatory Affairs Specialist/Practitioner (part-time role) in Salisbury, Wiltshire, United Kingdom, Contract/Project

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