Our client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. This role supports the development and execution of regulatory strategies for pipeline therapeutics across multiple indications. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
The Regulatory Affairs Specialist will be responsible for preparing and managing submissions to the FDA and select international regulatory bodies. This includes INDs, NDAs, BLAs, and annual reports, as well as responses to agency requests and deficiency letters. The specialist will also review promotional and labeling materials to ensure compliance with applicable regulations.
This is an individual contributor role suited to someone with hands-on submission experience who can operate with moderate autonomy. The company is advancing two programs through Phase II trials, so the pace is active and timelines are firm. Strong project management discipline and clear written communication are essential to succeed here.
The midpoint of this role’s $90,000–$125,000 range is $107,500 per year. Here is how that compares with live openings on Careerscape right now:
Figures are computed automatically from salary ranges on live Careerscape listings and update as jobs are added or filled. They are informational, not an offer guarantee.
This position pays $90,000 to $125,000 per year. The midpoint of $107,500 is above the $95,000 median for Biotechnology roles currently listed on our board.
This is a on-site position based in Boston, Massachusetts 02210.
This is listed as a Mid-Senior level role. See the Requirements section above for the specific qualifications the client is looking for.
Competitive base salary with annual performance-based bonus, Medical, dental, and vision insurance with low employee cost-share, 401(k) plan with 4% company match and immediate vesting, Flexible paid time off plus 12 company holidays, Annual professional development stipend for conferences and continuing education, Commuter benefits program including pre-tax transit and parking.
Posted on June 20, 2026 with 11 applications so far. Applying early is recommended, as our recruiters begin reviewing candidates as soon as applications come in.
Qualified applicants can typically expect a response within 5–7 business days of applying, though depending on the role and the client’s hiring timeline it can occasionally take up to 30 days. Because of the volume of applications we receive, we aren’t always able to send a personalized update to every applicant — but you can check the status of your application anytime in your candidate portal.
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