Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy... regulatory affairs preferred Experience with clinical trial and licensing requirements in all major countries in the region...
a Manager, Regulatory CMC to join the new and growing Post-Approval Group within the larger Regulatory Affairs Organization. The..., write, and review CMC sections of pertinent global regulatory submissions (e.g., marketing and post-approval applications...
a Manager, Regulatory CMC to join the new and growing Post-Approval Group within the larger Regulatory Affairs Organization. The..., and review CMC sections of pertinent global regulatory submissions (e.g., marketing and post-approval applications, annual...
for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory... internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical...
. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External...Job Description: Position Summary: The Manager position within Clinical Supply Chain leads end-to-end supply chain...
and study conduct Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current... Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance...
and study conduct Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current... Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance...
-functional teams, including Biostatistics, Clinical Operations, Translational Science, and Regulatory Affairs, to achieve project... reviewing clinical pharmacology sections of study protocols, reports, and regulatory submission documents. Work with cross...