Pharmaceutical Regulatory Affairs Specialist - Wiltshire, United Kingdom - Jobs in Science

Jobs in Science

Verified Company

Wiltshire, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Part-Time 22 hours a week. Initially based on site, then remote

2 year contract.

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 ) Good clinical practise)
Demonstrable experience of contributing to/preparing TPPs (Target product Profile), IBs (Investigator Brochure) and IMPDs (Investigational Medicinal Product Dossiers)
Demonstrable experience of preparing and/or managing CTAs (Clinical Trial Applications)
Demonstrable experience of interactions with Regulatory Authorities
Demonstrable experience of applying/constructing CTD (Common Technical Dossiers) document structures for pharmaceutical development projects to support MAAs (Marketing Authorisation Application)
Maintain currency in regulatory affairs regulations and requirements affecting pharmaceutical product development activities

Desirable:

Working knowledge of GMP (Good manufacturing practise) and GLP (Good laboratory practise)
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

Previous role titles might include:

Regulatory Manager
Regulatory Officer
Pharmaceutical Regulatory Affairs Specialist

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

Reference

PTPD
Location

Wiltshire