Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 12 of 15
Regeneron · Sleepy Hollow
Revolution Medicines · Redwood City, CA
Johnson & Johnson · Danvers, MA
AstraZeneca · Boston, MA +1 more
Revolution Medicines · Redwood City, CA
Thermo Fisher Scientific · Middletown, VA
Revolution Medicines · Redwood City, CA
Insmed · Corporate Headquarters, NJ
Rapport Therapeutics · Boston, MA
Kymera Therapeutics · Watertown, MA
Abbott · Abbott Park, IL
Revolution Medicines · Redwood City, CA
Stoke Therapeutics · Bedford, MA
IQVIA · Durham, NC
Revolution Medicines · Redwood City, CA
Gilead Sciences · El Segundo, CA +4 more
Johnson & Johnson · Titusville, NJ +3 more
Bristol Myers Squibb · Buenos Aires, AR
Abbott · Santa Clara, CA +1 more
Neurocrine Biosciences · San Diego
Neurocrine Biosciences · San Diego
Edwards Lifesciences · Irvine, CA
AstraZeneca · Boston, MA
Stryker · Portage, MI
AstraZeneca · Wilmington, DE
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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