Pharmaceutical Regulatory Affairs Specialist - Wiltshire, United Kingdom - Jobs in Science
Description
Part-Time 22 hours a week. Initially based on site, then remote2 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
Desirable - Higher qualification in pharmaceutical related field
Reference
PTPD
Location
Wiltshire
- Wiltshire_
Daily Rate
- Inside IR35_
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