Regulatory Affairs Talent in the Greater New Jersey Region

20 years

MS

CMC submissions, amendments, license renewals, IND, NDA, and CTD. Industry: Pharmaceutical

20 years

AS

eCTD submission coordination, document management, archiving documents, and EDMS. Industry: Pharmaceutical

15 years

PharmD

Regulatory affairs project management, CMC, eCTD, and IND/NDA submissions. Industry: Pharmaceutical

10 years

MS

CMC section preparation, Annual Product Review, and ANDA change approval. Industry: Pharmaceutical

10 years

AS

Preparing regulatory submissions, INDs, NDAs, and Annual Reports. Industry: Pharmaceutical

7 years

BS

Leading 510(k) submissions, technical files, developing regulatory strategies, and risk management. Industry: Medical Device

7 years

BS

CMC authoring/reviewing, supplements, annual reports, registration renewals, and health authority responses. Industry: Pharmaceutical

5 years

MS

IND, NDA, submissions, supplements, BLA, and Annual Reports. Industry: Pharmaceutical

3 years

BS

Submission document review, IND/NDA/BLA/ANDA, CMC documents, and labeling review. Industry: Pharmaceutical

3 years

BS

Reviewing labs/artwork, and preparing submissions. Industry: Consumer Product