Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
106 roles found · page 5 of 5
Vor Biopharma · Boston, MA
Orchard Therapeutics
Vaxcyte · San Carlos, California, United States
Recursion · New York, New York
Twist Bioscience · USA - South San Francisco, CA
Vertex Pharmaceuticals · Boston, MA
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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