Every result a biotech lab produces eventually has to survive scrutiny from a regulator who was not in the room when it was generated, and someone has to build the paper trail that makes that survival possible. That is the core of this Regulatory Affairs Associate role: a full-time, fully remote position with no fixed office or city attached to it, open to candidates anywhere. The paperwork is not an afterthought to the science here; in a regulated field, undocumented work is functionally the same as work that never happened.
The position pays $90,000 a year and sits within a Biotech and Deep Tech portfolio, working alongside lab, quality, and compliance teams rather than reporting into a single physical site. Regulatory affairs as a function sits at the intersection of science and paperwork, and it rewards people who find that intersection interesting rather than tedious.
Candidates typically hold a bachelor's degree in biology, chemistry, or a related life-sciences field. On top of that, one year of hands-on laboratory or research experience is expected, enough time to have handled protocols and documentation under supervision at least once. Attention to detail matters more here than almost anywhere else on a life-sciences team, since a misrecorded value in a lab notebook can ripple into a regulatory filing months later.
The twelve-month experience benchmark is a floor, not a ceiling. Someone straight out of an undergraduate research lab with a single well-documented project can meet it, provided they can point to specific work: a protocol they followed, data they logged, an audit they helped prepare for. What the role does not require is prior regulatory affairs job title experience specifically, since the documentation habits transfer more easily than people expect.
Much of the job involves reviewing and recording experimental data generated by lab partners, then checking it against established protocols before it moves into a formal file. The associate does not always run the bench work directly, but is accountable for making sure it is documented correctly and consistently.
A typical week might involve reconciling three separate lab notebooks against a single study protocol to confirm nothing was recorded out of sequence, then writing up a short summary for the compliance lead. It is detail work, but the kind that a regulatory submission genuinely depends on. Some weeks are quieter, mostly filing and updating logs; other weeks build toward an internal audit or a submission deadline, and the pace picks up accordingly.
The strongest candidates are not necessarily the most senior scientists, but the ones who treat documentation as part of the science rather than as an obstacle to it. Someone coming out of an academic lab, an industry internship, or a contract research organization can all fit here, as long as they can describe specific instances of following a protocol under review and can talk through how they handled a discrepancy when they found one. A methodical temperament matters more than raw lab hours.
A regulatory affairs associate who cannot explain why a protocol deviation happened, in writing, clearly, is going to struggle here regardless of lab skill.
Nice to have, though not required at this level: prior exposure to electronic lab notebook systems, familiarity with FDA or ICH documentation standards, and any coursework in quality assurance. None of these are dealbreakers on their own if the core documentation discipline is there.
Writing ability deserves a specific mention, since it rarely shows up on a skills list but matters constantly in practice. A regulatory associate spends a fair amount of time turning raw observations into plain, defensible written statements. Someone who can write a clear paragraph about a protocol deviation, without hedging or padding, tends to move faster through review cycles than someone with stronger lab skills but weaker writing.
Beyond the $90,000 base salary, this full-time role includes a standard set of employee benefits, with specifics varying somewhat by final offer.
Remoteroles lists postings like this one because remote-first structures are becoming more common in regulatory affairs specifically, not just in adjacent tech roles, as more biotech companies shift lab and compliance coordination to distributed teams.
There is no lab bench attached to this job description and no city requirement. Work happens through shared documentation systems, scheduled reviews, and video check-ins with the quality and compliance teams, generally a few hours of overlap during a standard business week to accommodate live protocol reviews. Outside of scheduled meetings, most of the documentation and review work can be done asynchronously, provided deadlines around audit windows are respected. Candidates should expect occasional weeks with tighter turnaround, usually tied to a filing deadline, alongside quieter weeks focused on routine documentation upkeep. Time zone is not a filter for this role; what matters is showing up reliably for the scheduled reviews and keeping the shared documentation systems current in between them.
Interested candidates should submit a resume along with a short summary of prior lab or research documentation experience. Applications are reviewed on a rolling basis, and candidates who move forward can expect a first conversation with the hiring manager followed by a brief documentation exercise before a final decision. That exercise usually involves reviewing a sample dataset for inconsistencies, which gives both sides a realistic sense of the day-to-day work before any offer is made.