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.
Job Posting Title:FX Design & VFX Intern, Spring 2027Req ID:10160082Job Description:About the Role & ProgramThe FX Motion Design... ...show. Made up of storytellers, artists, designers, editors, animators, 3D artists, and production artists, the team brings creative...
...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic... ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation...
...School-Based PT Opportunity (Antioch, CA)Ascends mission is to grow, learn, and develop like the children we serve. We believe every day... ...families. Our ideal candidate must have an active California Physical Therapy license and be comfortable working with various disabilities...
...We are hiring a contract 3D artist to own our stylized asset pipeline end-to-end, from originating 2D concepts through modeling, texturing, rigging, and animating in 3D, delivered as pre-rendered animation. Responsibilities Originate 2D concept art for main app character...
...General information Job Title Airport Ramp Agent (Delta) LIH - Driving/PM-RR Date Monday, September 7, 2026 Entity Unifi Aviation, LLC State Hawaii City Lihue Base Pay Rate: $ 18.00 Full/Part...