Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 9 of 15
Abbott · Santa Clara, CA +5 more
Gilead Sciences · Foster City, CA
Nurix Therapeutics · Brisbane, CA
Allucent
Medtronic · Mounds View, MN
IQVIA · Durham, NC
IQVIA · Washington, DC
Danaher · Chaska, MN
Edwards Lifesciences · USA IRV-1442 Alton/mic
Danaher · New Port Richey, FL
Abbott · Santa Clara +1 more
Abbott · Alameda, CA
Becton Dickinson · Sparks, MD
Abbott · Santa Clara, CA +1 more
Abbott · Alameda, CA
PTC Therapeutics · Warren, NJ
Sarepta Therapeutics · US
Becton Dickinson · Franklin Lakes, NJ
Lyell Immunopharma · Seattle, WA +1 more
Bristol Myers Squibb · Princeton, NJ +4 more
IQVIA · Durham, NC
Bristol Myers Squibb · Princeton, NJ +2 more
Amgen · Holly Springs, NC
Amgen · Thousand Oaks, CA
Amgen · Holly Springs, NC
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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