Regulatory affairs jobs
Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 15 of 15
Insitro · South San Francisco, CA
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- 1d ago
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Gilead Sciences · Foster City, CA
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- 1d ago
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About regulatory affairs roles
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.
Common job titles
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Director, Regulatory Affairs
- Regulatory CMC Lead
- Regulatory Operations / Publishing Specialist
- Labelling Manager
Also searched for
Roles in this area are also listed as regulatory affairs jobs, RA jobs, regulatory submissions jobs and regulatory strategy jobs.
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