Regulatory Affairs Consultant

Fully Remote

3-6 Months Hourly Rate

Qualifications/Skills

Experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements (on this occasion someone with at least 60% CMC and 40% Device) and a fast learner.

Below a very top-level list (can provide detailed list later).

• Bachelor’s Degree (or higher) in a relevant scientific or engineering field.
  
  
• Experience in regulatory affairs within the medical device, CMC or Drug-Device combination product industry, preferably from pharmaceutical industry or from a regulatory agency.
  
  
• Demonstrated understanding of and ability to interpret regulations and guidelines governing pharmaceutical products and medical devices.
  
  
• Strong knowledge of regulatory submission processes and global regulatory frameworks.
  
  Focused work for Q1 2025:
  
  
• Regulatory support to O1 Device Development (DD) team and activities e.g. final review, comment and approval of existing device-related technical documentation including device verification and validation documents, device specifications, risk management, human factors, biological evaluation, device labelling, IFU/QRG, End of Phase review and advising on interpretation of legislation/guidance, attending internal device development meetings.
  
  
• Regulatory CMC support to Pharmaceutical Development (PD) team e.g. final review, comment and approval of pharm dev protocols and reports (pharm dev and stability), SPECs (bulk, final product, per strength), justifications of specs, shelf life justifications, QTPP, batch manufacture documents, Product History File, Technical Risk Assessments, Product Specification File, Product Specification Index, QTAs, labelling and packaging text, advising on interpretation of legislation/guidance, attending internal CMC meetings
  
  
• Review of CCRs raised by other functions (e.g. assessment of impact on regulatory submissions and approval of CCRs)
  
  
• Review of Device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator’s Brochure
  
  
• Reviewing and supporting CMC and Device sections of the Clinical Trial Notification in Australia