Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
106 roles found · page 4 of 5
Dyne Therapeutics · Waltham, MA
Nurix Therapeutics · Brisbane, California, United States
Dyne Therapeutics · Waltham MA or Remote
Erasca · San Diego, CA, South San Francisco, CA or remote
Nurix Therapeutics · Brisbane, California
Vaxcyte · San Carlos, California, United States
BridgeBio Pharma · San Francisco - 1800 Owens
Neurocrine Biosciences · US CA San Diego
PTC Therapeutics · USA - New Jersey - Warren
Neurocrine Biosciences · US CA San Diego
Illumina · England - Cambridge
Neurocrine Biosciences · CH Allschwil
Neurocrine Biosciences · US CA San Diego
Iovance Biotherapeutics · Remote
Alumis · South San Francisco
Vaxcyte · San Carlos, California, United States
Iovance Biotherapeutics · Remote
Orchard Therapeutics
Iovance Biotherapeutics · Remote
BridgeBio Pharma · Washington DC
Vor Biopharma · Boston, MA
Iovance Biotherapeutics · Remote
Iovance Biotherapeutics · Remote
Iovance Biotherapeutics · Remote
Iovance Biotherapeutics · Remote
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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