Reference: 630467Posted: 2026-09-14Location: Cambridge, MassachusettsCompany: Planet Pharma GroupContact: ApplicationsEmail: applications@staffingfuture.comLocation: Watertown, MA – Hybrid, 2-3 days/week onsiteReports to: Chief Medical OfficerPosition SummaryThis individual will lead regulatory strategy and execution for growing clinical-stage oncology pipeline. The role will work closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners to advance programs through Phase 1 and Phase 2 development in the U.S., EU, and UK.This is a hands-on role for someone who can think strategically, work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows.Key ResponsibilitiesDevelop and execute regulatory strategy for Phase 1 and Phase 2 oncology programs. Lead INDs, CTAs, amendments, and other regulatory submissions. Lead and coordinate interactions with FDA and international health authorities. Support clinical development across the U.S., EU/CTIS, and UK/MHRA. Partner with Clinical, CMC, and Quality teams on regulatory strategy and development decisions. Provide regulatory guidance on protocols, development plans, CMC changes, and clinical trial expansion. Manage external regulatory consultants and vendors as needed. Establish practical regulatory processes and infrastructure appropriate for a growing biotech. Help build the Regulatory Affairs function as additional programs enter clinical development. QualificationsSignificant Regulatory Affairs experience within biotechnology or pharmaceutical drug development. Strong experience supporting Phase 1 and Phase 2 oncology programs. Demonstrated experience with U.S. INDs and FDA interactions. Strong experience with EU CTAs/CTIS required. UK/MHRA regulatory experience strongly preferred. Experience developing and executing regulatory strategy, not solely regulatory operations. Working knowledge of CMC regulatory considerations during early clinical development. Small or mid-sized biotech experience strongly preferred. Ability and willingness to remain hands-on while operating as the internal regulatory lead.
...Full-Time Medical Assistant OpportunityEmergency One is looking to hire Full-Time Medical Assistants, no experience required. We offer training to those who are serious about a career in healthcare and would like the opportunity to learn new skills. Consider joining a...
...Metals Co. Inc. is a growing, family-owned precision sheet metal contract manufacturer in St. Michael, MN recruiting for a Powder Coat Painter to join our team. We have over 50 years of success and steady growth. Work in our ultra-clean, air-conditioned 111,000...
...UI/UX Design Intern Treehouse Strategy, a New York-based software startup is looking for a UI/UX designer intern. This is an unpaid internship position. Develop UI mockups and prototypes that clearly illustrate how sites function and look like Create original...
...always a GOOD day in SoCal! Deliver Goods Safely While Supporting Our Mission. Goodwill Southern California is hiring a Truck Driver Class C to operate bobtail trucks transporting goods between retail stores and designated facilities. This role focuses on safety, service...
...stores, ice cream shops, and schools with high-quality dairy products. About the role ~ We are seeking a dedicated Truck Driver to join our team at Cedar Crest Dairy Inc. In this role, you will be responsible for transporting our products to various customers...