About this Role:
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed. What You’ll Do: You must exhibit excellent operational competences, including planning, organizing and other project management skills.Remote Data Entry Clerk Earn At Home Usa Part Time Typing This is your chance to begin a long-lasting career with limitless opportunity... ...Safe workplace - Multiple shifts are offered from morning to night and no experience is needed. - You will have adequate...
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