Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 2 of 15
Amgen · Remote
Biogen · Remote
Amgen · Remote
Iovance Biotherapeutics · Remote
Iovance Biotherapeutics · Remote
Iovance Biotherapeutics · Remote
Natera · Remote
Adaptive Biotechnologies · Remote
Adaptive Biotechnologies · Remote
Johnson & Johnson · Santa Clara, CA +1 more
Revolution Medicines · Remote
Revolution Medicines · Remote
Amgen · Remote
argenx · Remote
Mineralys Therapeutics · Remote
argenx · Remote
Agilent · CA
Absci · Remote
Repligen · Remote
LivaNova · Remote
Danaher · Remote +1 more
Insmed · Corporate Headquarters, NJ
Exelixis · Alameda, CA
Medtronic · Irvine, CA
CONMED · CO
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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