Clinical Regulatory Intelligence Analyst / Consultant

Leading pharmaceutical company require a consultant to help with clinical regulatory intelligence.

Skills: Regulatory Intelligence platforms, Agile BA, Regulatory Affairs/Operations, submissions, eCTD, CMC

Experience

• 59 years experience (4+ minimum) in pharma / life sciences consulting or delivery
• Regulatory Affairs / Regulatory Operations experience
• Hands-on work with Regulatory Intelligence platforms
• Strong exposure to eCTD, submissions, labeling, CMC variations
• Understanding of Regulatory Intelligence lifecycle (capture ? curate ? consume
• Ability to independently lead a workstream and work directly with client stakeholders
• Business Analysis / Consulting skills
• Requirements gathering
• User stories
• Gap analysis & future-state design
• Agile delivery experience (mandatory)
• Experience with SaaS platform implementations
• Strong communication and stakeholder-management skills

This is a fully remote contact offering £350 per day for a 12 month contract, outside of IR35.

Ideally start within 2 weeks of offer (end Jan)

JBRP1_UKTJ