Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
106 roles found · page 1 of 5
Stryker · Bengaluru, India
Amgen · India - Hyderabad
Bristol Myers Squibb · Beijing - CN
Bristol Myers Squibb · Warsaw-WeWork-PL
Biogen · Tokyo, Japan
Biogen · Baar, Switzerland
IQVIA · Frankfurt, Hesse, Germany
Regeneron · 2 Locations
Gilead Sciences · United States - California - Foster City
Edwards Lifesciences · USA - California – Irvine
Stryker · Selzach, Switzerland
Regeneron · 2 Locations
Regeneron · 2 Locations
Edwards Lifesciences · Malaysia-Kuala Lumpur BSC
IQVIA · Sofia, Bulgaria
IQVIA · Bucuresti, Romania
IQVIA · 8 Locations
Regeneron · 2 Locations
Biogen · Remote, USA
Gilead Sciences · 2 Locations
Amgen · India - Hyderabad
Gilead Sciences · United States - California - Foster City
IQVIA · Budapest, Hungary
IQVIA · 4 Locations
Bristol Myers Squibb · 4 Locations
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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