#5330747
20 years
PhD
Experience authoring CMC sections, preparing submissions, INDs, BLAs, annual reports, and amendments. Industries: Pharmaceutical, Biotechnology
#5110573
20 years
BS
Experience writing product registration applications, IDEs, 510(k), and IND. Industry: Biopharmaceutical, Medical Device
#1606373
14 years
MS
Experience in 510k preparation, product registration tracking, and pre-IDE packages. Industry: Medical Device
#1227007
5 years
MS
Experience preparing submissions, 510(k), IDE, PMA, ANDA/NDA/IND, and labeling review. Industries: Medical Device, Pharmaceutical
#5254827
1 year
MS
Experience authoring/submitting IND, Amendments, and Annual Reports. Industry: Biopharmaceutical, Medical Device
#5330753
20 years
MS
Experience in developing regulatory strategies, remediation, and FDA submissions. Industry: Medical Device
#5330749
14 years
BS
Experience in regulatory submissions, 510(k), IDE, and labeling review. Industries: Medical Device, Pharmaceutical
#5281112
6 years
Master's
Experience in post-approval filing strategies, NDA/ANDA label submissions, CMC support, and eCTD. Industry: Medical Device
#1539963
8 years
Bachelor's
Experience in CMC management, annual reports, site registrations, 510(k), and CE mark. Industries: Medical Device, Pharmaceutical
#2157430
9 years
Bachelor's
Experience in reviewing promotional materials, advertising, labelling, and FDA submission management. Industry: Pharmaceutical
Job Title: Regulatory Affairs Consultant
City: Boston
Candidate(s):