Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
106 roles found · page 2 of 5
Gilead Sciences · United States - California - Foster City
IQVIA · Belgrade, Serbia
Bristol Myers Squibb · Warsaw-WeWork-PL
Bristol Myers Squibb · Princeton - NJ - US
Edwards Lifesciences · Mexico-Mexico City
Regeneron · 2 Locations
Biogen · Cambridge, MA
Edwards Lifesciences · Malaysia-Kuala Lumpur BSC
Regeneron · RENSS - GLOBAL VIEW
Biogen · New Delhi, India
IQVIA · 2 Locations
Amgen · Netherlands - Breda
Amgen · United States - Remote
Bristol Myers Squibb · Warsaw-WeWork-PL
Stryker · Taikoo Shing, 12 Taikoo Wan Road
Amgen · 4 Locations
Edwards Lifesciences · USA-California-Hybrid
Regeneron · 2 Locations
Gilead Sciences · Ireland - Dublin
Edwards Lifesciences · USA - California – Irvine
Amgen · South Africa - Johannesburg
Edwards Lifesciences · China-Beijing
Gilead Sciences · China - Beijing
Amgen · United States - Remote
Gilead Sciences · Ireland - Dublin
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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