Regulatory Affairs Talent in the Greater Boston Region

20 years

PhD

Experience authoring CMC sections, preparing submissions, INDs, BLAs, annual reports, and amendments. Industries: Pharmaceutical, Biotechnology

20 years

BS

Experience writing product registration applications, IDEs, 510(k), and IND. Industry: Biopharmaceutical, Medical Device

14 years

MS

Experience in 510k preparation, product registration tracking, and pre-IDE packages. Industry: Medical Device

5 years

MS

Experience preparing submissions, 510(k), IDE, PMA, ANDA/NDA/IND, and labeling review. Industries: Medical Device, Pharmaceutical

1 year

MS

Experience authoring/submitting IND, Amendments, and Annual Reports. Industry: Biopharmaceutical, Medical Device

20 years

MS

Experience in developing regulatory strategies, remediation, and FDA submissions. Industry: Medical Device

14 years

BS

Experience in regulatory submissions, 510(k), IDE, and labeling review. Industries: Medical Device, Pharmaceutical

6 years

Master's

Experience in post-approval filing strategies, NDA/ANDA label submissions, CMC support, and eCTD. Industry: Medical Device

8 years

Bachelor's

Experience in CMC management, annual reports, site registrations, 510(k), and CE mark. Industries: Medical Device, Pharmaceutical

9 years

Bachelor's

Experience in reviewing promotional materials, advertising, labelling, and FDA submission management. Industry: Pharmaceutical