Regulatory Affairs Talent in the Greater Boston Region

20 years

MBA

Risk management, 510(k), IDE, and MDR. Industry: Medical Device

20 years

BS

FDA submissions, promotional material review, 510k, PMA, and BLA. Industries: Biotechnology, Pharmaceutical

20 years

BS

CMC leadership, submissions, NDAs, CTAs, INDs, DMFs, and eCTD format. Industries: Pharmaceutical, Medical Device

15 years

PhD

Regulatory strategies, IND/CTA, NDA/MAA/BLA submissions, Annual Reports, and CTD content development. Industry: Biopharma

7 years

BS

Investigations, deviations, labeling supplements, and promotional materials. Industry: Pharmaceutical

6 years

BS

Preparing submissions, technical files, CE marking, product registration, and 510(k). Industry: Medical Device

6 years

MS

MDR, registration management, and 510(k) submissions. Industry: Medical Device, Pharmaceutical

5 years

BS

Preparing Healthy Authority submissions, CMC support, IND/NDA submissions, and amendments. Industry: Pharmaceutical

1 year

MS

Preparing submissions, ANDA, IND, NDA, supplements, and eCTD format. Industry: Pharmaceutical