Jobs 1 - 9 out of 9 for Regulatory Affairs Scientist

Prepare and review regulatory and scientific documents for drugs, biologics, and medical devices. Support regulatory strategy and Health Authority interactions, including meeting preparation and responses to inquiries. Translate regulatory guidance and submission requirements into practical plans fo...

Since 1869, we've connected people through food they love. We’re proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell’s brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao’s Hom...

The Senior Principal Scientist SRA COE serves as the global lead for evaluating, interpreting and proactively forecasting emerging scientific and regulatory developments on ingredients and packaging. This role develops globally aligned regulatory and scientific positions and strategies, maintains ro...

Develop regulatory pathways and approval strategies, lead preparation and review of FDA submissions, serve as regulatory lead for assigned programs, provide regulatory risk assessments and mitigation strategies, support FDA meetings and agency interactions, create and maintain Target Product Profile...

Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs. Be accountable for the delivery of all regulatory milestones through product development and post-approval lifecycle. Develop and...

Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs. Develop and execute global Regulatory CMC strategies for drug-linkers and other chemically synthesized moieties. Manage preparati...

Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs. Develop and execute robust, phase-appropriate global Regulatory CMC strategies for drug-linkers and other chemically synthesized ...

Lead submission strategies and regulatory interactions for innovative medical products. Develop and execute regulatory strategies and submission plans, prepare and submit INDs, NDAs, BLAs, and IDEs, serve as primary liaison with FDA and regulatory agencies, provide regulatory guidance to cross-funct...

Support the Office of Regulated Activities by ensuring compliance with FDA responsibilities, providing subject matter expertise on regulatory strategy, and assisting integrated project teams with submissions and communications. Develop regulatory strategies and maintain Target Product Profiles, iden...