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
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...Job DescriptionPrimary Location: Worland, WyomingLine Operator Supervisor: Supervises and coordinates activities of production workers in... ...specifications and directs setup and adjustments of machines.Monitors line operation to ensure all safe guards and interlocks are...
...Liberated People is looking for an MBA Fashion Management intern to assist in product development, branding, and marketing. The intern will strategize growth for our eco-friendly apparel line and work in a fast-paced environment.This unpaid position requires 5-10 hours...
...Waste Connections is looking for a safety conscience Driver Helper to join our growing team in Selmer, TN. DUTIES AND RESPONSIBILITIES: Ability to safely operate on and around a garbage truck on specified routes to collect solid waste. Ability to...
...Receptionist for Pediatric Dentist M, W, F in Oakhurst NJ Looking for a vibrant and friendly Receptionist for our Oakhurst NJ office. No nights or weekends. Computer experience required. Dental experience a plus. Send a Resume in Docx or PDF format Title Pediatric...