Regulatory Affairs Consultant
Location: Fully Remote
Duration: 3-6 Months Hourly Rate
Qualifications/Skills:
Experienced in supporting development projects and has worked on drug-device combination products. Knowledge of CMC and Device requirements (60% CMC and 40% Device) is essential. A fast learner is preferred.
1. Bachelor's Degree (or higher) in a relevant scientific or engineering field.
2. Experience in regulatory affairs within the medical device, CMC, or Drug-Device combination product industry, preferably from the pharmaceutical industry or a regulatory agency.
3. Demonstrated understanding of and ability to interpret regulations and guidelines governing pharmaceutical products and medical devices.
4. Strong knowledge of regulatory submission processes and global regulatory frameworks.
Focused work for Q1 2025:
1. Regulatory support to O1 Device Development (DD) team and activities, including final review, comment, and approval of existing device-related technical documentation such as device verification and validation documents, device specifications, risk management, human factors, biological evaluation, device labeling, IFU/QRG, End of Phase review, and advising on interpretation of legislation/guidance, attending internal device development meetings.
2. Regulatory CMC support to Pharmaceutical Development (PD) team, including final review, comment, and approval of pharm dev protocols and reports (pharm dev and stability), specifications (bulk, final product, per strength), justifications of specifications, shelf life justifications, QTPP, batch manufacture documents, Product History File, Technical Risk Assessments, Product Specification File, Product Specification Index, QTAs, labeling and packaging text, advising on interpretation of legislation/guidance, attending internal CMC meetings.
3. Review of CCRs raised by other functions, including assessment of impact on regulatory submissions and approval of CCRs.
4. Review of Device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator's Brochure.
5. Reviewing and supporting CMC and Device sections of the Clinical Trial Notification in Australia.
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