Lead Regulatory Affairs for Cognito Therapeutics, championing strategic regulatory pathways for innovative neuro therapies. Spearhead collaborations across teams, drive submissions, and uphold compliance standards. Requires 10+ years in Regulatory Af...
Seeking a skilled Process Engineer with 4+ years of experience in FDA and GMP standards. Responsible for designing manufacturing processes, ensuring safety, providing technical support, and ensuring compliance. Full-time position offering $54.00 per ...
Lead global Regulatory Affairs CMC strategies for gene therapy products, ensuring compliance, successful submissions, and health authority approvals. Collaborate with internal teams, prepare submissions, and engage with regulatory authorities. Overse...
Lead Regulatory Affairs Director at eGenesis. Spearhead IND, IMPD, and CTA submissions, ensuring compliance. Drive strategies for xenotransplantation therapies at the forefront of FDA regulations. Oversee CMC report preparation and collaborate with c...
Lead regulatory projects for medical devices, ensuring timely submissions. Provide strategic guidance to teams, stay current on regulations, and drive FDA interactions. 3+ years of US RA experience with class I-III devices required. Strong communicat...
Seeking Business Analyst/Business System Analyst in Cambridge, MA. Requires expertise in agile methodology, data systems/tools, Pharma/Life Sciences, GxP regulations, clinical trial data, safety data, CSV/SDLC processes, and Pharma-related technologi...
Seeking a Clinical Trial Manager to spearhead global operations for complex clinical research projects. Responsible for ensuring study timelines, quality, and regulatory compliance. Leading cross-functional teams and managing external vendors. Must h...
Lead Human Factors & Usability Engineer role at Sanofi's Global Device & Packaging Unit. Oversee user needs, usability engineering for medical devices like Insulin Pens. Conduct usability studies for device efficacy, collaborate with teams for optima...
Seeking Senior Corporate Counsel for Sanofi Legal Department. Advise on pharmaceutical products within Specialty Care Unit. Handle intricate legal matters, ensure compliance, and support business initiatives. Must possess strong legal acumen, busines...
Seeking Remote Principal Statistical Programmer with 10+ years in Pharmaceutical/Biotech programming, including macro/tools dev. Strong SAS skills, FDA exp preferred. Manage projects, lead studies, automate programming activities. Full-time role, $12...
