Leading the regulatory function for clinical-stage radiopharmaceutical programs, the full-time salaried Head of Regulatory Affairs will define global regulatory strategy, manage key submissions, and engage with health authorities while working remotely. Key Responsibilities Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs Lead key regulatory submissions, including INDs, CTAs, and DMFs Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities Required Qualifications Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries In-depth knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations Proven track record of successful regulatory submissions, including INDs, NDAs, and BLAs Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas
...Plastic Extrusion Operator Code: 705418 Location: OH - Conneaut Contact: Machine Operators needed in Conneaut for a premier facility working Monday-Friday 6:45am-3pm. This is a temp to hire role starting out at $15.50 an hour. Role and...
Job-ID31683224Reference26-00010 Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets...
...plans and drawings (will train) Pay based on experience MANUFACTURING WOODWORKERS ~2+ years of experience in the manufacturing of... ...methods of cabinetry and countertops. Experience with plastic lamination techniques a plus. ~ Knowledge of AWI standards....
...client is seeking a skilled Maintenance Technician to join their manufacturing team. In this role, you will be responsible for maintaining,... ...Maintenance, Mechatronics, or related field Experience in plastic manufacturing or high-speed packaging environments...
...Overview of the Position The U.S. District Court for the Southern District of Illinois is... ...for the position of Official Court Reporter. This is a part-time permanent position located... .... Louis courthouse will be required.The federal Judiciary is an Equal Employment...