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
...shape the future of aerospace and defense. The full scope of Flight Attendant responsibilities in support of RTX-owned or leased aircraft... ..., records management, process improvement, safety reporting, training support and office or facility organization. Maintain...
...outbound calls while maintaining HIPAA and privacy compliance Accurately document interactions using pharmacy systems, Salesforce/CRM platforms, Microsoft Excel, and Word LICENSES & CERTIFICATIONS Current, active Pharmacy Technician license/registration...
...Additional Information About the Role BJC HealthCare is now hiring a Neuro Interventional Radiologic Technologist at our Barnes... ...Certification as a Registered Technologist in Radiography - R.T.(R) Experience: ~ New grads, upcoming grads students, Student Radiology...
...Role- IBM Maximo Location - Dallas TX (onsite) Job type- W2 Contract Job description Below Experience: 3-7 years; junior candidates with relevant experience may also be considered. Hands-on experience in IBM Maximo development and customization...
...ODORZX INC. is a leading automotive company specializing in odor elimination solutions. We are currently seeking a talented Chemical Engineer to join our team. As a Chemical Engineer at ODORZX INC., you will be responsible for developing and implementing innovative solutions...