Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
106 roles found · page 3 of 5
Edwards Lifesciences · Malaysia-Kuala Lumpur BSC
Stryker · Cork, Ireland
Biogen · Cambridge, MA
IQVIA · Athens, Greece
IQVIA · Dublin, Ireland
Gilead Sciences · Japan - Tokyo
Bristol Myers Squibb · Warsaw-WeWork-PL
Regeneron · 2 Locations
Bristol Myers Squibb · Otemachi-JP
IQVIA · Ljubljana – Dunajska, Slovenia
Regeneron · RENSS - GLOBAL VIEW
Gilead Sciences · United States - California - Foster City
Stryker · Bengaluru, India
Edwards Lifesciences · 2 Locations
Agilent · 2 Locations
Regeneron · 2 Locations
Bristol Myers Squibb · Hyderabad - TS - IN
IQVIA · Bucuresti, Romania
Stryker · 4 Locations
Gilead Sciences · 2 Locations
Ascendis Pharma
Biomapas
Neurocrine Biosciences · US CA San Diego
Sarepta Therapeutics · Cambridge, MA
Nurix Therapeutics · Brisbane, California, United States
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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