Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 14 of 15
Zimmer Biomet · Englewood, CO
Merck · North Wales (upper Gwynedd), PA +1 more
Thermo Fisher Scientific · Greenville, NC
Gilead Sciences · Foster City, CA
Cytokinetics · South San Francisco, CA
Baxter · Round Lake, IL
Treace Medical · Ponte Vedra, FL
Merck · Rahway, NJ +2 more
Merck · North Wales (upper Gwynedd), PA
AbbVie · Irvine, CA
Vertex Pharmaceuticals · Boston, MA
QuidelOrtho · US
Vertex Pharmaceuticals · Boston, MA +1 more
Merck · North Wales (upper Gwynedd), PA +1 more
Merck · Rahway, NJ +1 more
Bioventus · Durham, NC
Merck · Rahway, NJ
Cytokinetics · Radnor, PA
Thermo Fisher Scientific · Allentown, PA
IQVIA · Durham, NC +3 more
IQVIA · Washington, DC
Bristol Myers Squibb · Rayzebio, IN
LGC Group · Milford, MA
Becton Dickinson · Franklin Lakes, NJ +16 more
Regulatory affairs is the interface between a company and the health authorities that decide whether its product reaches patients. The work spans strategy (what evidence a filing needs and when), operations (assembling and publishing submissions in eCTD format), and labelling and advertising review post-approval. Drug-side roles are framed around INDs, NDAs, BLAs and MAAs; device-side roles around 510(k), De Novo, PMA and EU MDR technical documentation — the two tracks are related but rarely interchangeable, so postings usually specify.
Roles in this area are also listed as regulatory affairs jobs, RA jobs, regulatory submissions jobs and regulatory strategy jobs.
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