Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 3 of 15
Exelixis · Alameda, CA
Medtronic · Irvine, CA
CONMED · CO
AstraZeneca · Juncos
Danaher · Sunnyvale, CA
Merck · North Wales (upper Gwynedd), PA +1 more
Gilead Sciences · Santa Monica, CA +3 more
AstraZeneca · Gaithersburg, MD
Sarepta Therapeutics · Cambridge, MA
Nurix Therapeutics · Brisbane, CA
Medtronic · Mounds View, MN
AstraZeneca · Gaithersburg, MD
AstraZeneca · Gaithersburg, MD +1 more
Becton Dickinson · Covington BMD, GA
Johnson & Johnson · Irvine, CA
Baxter · Deerfield, IL
AstraZeneca · Cambridge Kendall SQ, MA
Thermo Fisher Scientific · Greenville, NC
Orthofix · Bussolengo
Insmed · Corporate Headquarters, NJ
AbbVie · Irvine, CA
AbbVie · Florham Park, NJ
Thermo Fisher Scientific · Allentown, PA
Thermo Fisher Scientific · Allentown, PA
AbbVie · Florham Park, NJ
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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