Regulatory Affairs Specialist
3 days ago
We are seeking an experienced Regulatory Affairs Consultant to join our team at LennTech Search. This is a fully remote position that requires 3-6 months of commitment with an hourly rate.
Key Responsibilities- Provide regulatory support to the O1 Device Development (DD) team, including final review, comment, and approval of device-related technical documentation.
- Offer regulatory CMC support to the Pharmaceutical Development (PD) team, encompassing the review and approval of pharm dev protocols and reports, SPECs, 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.
- Review CCRs raised by other functions, assessing their impact on regulatory submissions and approving them accordingly.
- Examine device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator's Brochure.
- 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.
The estimated salary for this position is $150-$200 per hour, based on industry standards and location.
This role will be focused on supporting various projects, including device development and CMC activities, and will involve reviewing and approving technical documentation, assessing the impact of changes on regulatory submissions, and examining clinical documents. The ideal candidate will have experience in regulatory affairs, particularly in the medical device and pharmaceutical industries, and possess strong knowledge of regulations and guidelines governing these fields.
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Regulatory Affairs Specialist
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