A company is looking for a Sr. Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities.
Key ResponsibilitiesPrepare and oversee complex regulatory CMC submissions for investigational and commercial productsCollaborate with cross-functional teams to develop CMC submission plans aligned with business objectivesLead interactions with FDA and other Health Authorities regarding CMC-related topicsRequired QualificationsExperience in Regulatory Affairs CMC or relevant industry experience with an advanced degreeExperience with Life Cycle ManagementDemonstrated track record of managing CMC Regulatory activities in a global matrix team environmentDeep understanding of global regulatory requirements and guidelines
Senior Manager Regulatory Affairs
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
Senior Manager, CMC Regulatory Affairs, Biologics - Foster City, CA or 100% REMOTE
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. An in-depth knowledge of ICH and regional CMC regul...
Senior Pricing Manager- Public Affairs
Ipsos Public Affairs has an opportunity for a Senior Pricing Manager. As Senior Pricing Manager you will be responsible for managing the cost and price proposal process, as well as providing overall project financial support, for a vast portfolio of projects for both public and private sector client...
Senior Analyst Regulatory Affairs
A company is looking for a Senior Analyst, Regulatory Affairs to join their Corporate Counsel team. ...
Corporate Affairs Senior Manager - Oncology
Senior Manager, Corporate Affairs - Oncology. Lets do this! Lets change the world! In this vital role Amgen is seeking a Senior Manager of Corporate Affairs to develop and deliver strategic global communications for Amgen's diverse Oncology portfolio. The Senior Manager will report directly to the D...
Regulatory Affairs Manager
Coordinate and manage contacts with consultants and advisors on regulatory issues such as interpretation of regulations, regulatory submissions and other relevant regulatory issues;. More specifically, this position is responsible for responding to regulatory proposals, engaging with regulators, and...
Senior Counsel, Product and Regulatory Affairs (Liquidity)
You will play an immediate and direct role as Senior Counsel, with responsibility for: (i) supporting Circle’s Product Team in the development of novel digital asset products and (ii) offering clear, concise regulatory advice to Circle’s business teams relating to U. Biglaw experience, including lea...
PLS Regulatory Senior Manager
The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters. Ab...
Regulatory Affairs Manager
Coordinate and manage contacts with consultants and advisors on regulatory issues such as interpretation of regulations, regulatory submissions and other relevant regulatory issues;. More specifically, this position is responsible for responding to regulatory proposals, engaging with regulators, and...
Financial Risk & Regulatory - ALM/Balance Sheet - Senior Manager
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business ...