Project Manager
Kforce
Kforce's client in Deerfield, IL is seeking a Project Manager.
Overview:
We are seeking a highly skilled and motivated Regulatory Affairs Project Manager to join our team. This role will be pivotal in supporting the successful spin-off of one of our divisions. The Regulatory Affairs Project Manager will work closely with various divisions, including supply chain, labeling, and manufacturing, to ensure compliance with regulatory requirements and facilitate a smooth transition.
Key Responsibilities:
* Lead and manage regulatory projects related to the spin-off, ensuring timelines and deliverables are met
* Ensure all activities comply with relevant regulatory requirements, including FDA, EMA, and other global regulations
* Work closely with supply chain, labeling, and manufacturing teams to support regulatory needs and ensure alignment across divisions
* Prepare, review, and submit regulatory documentation, including submissions, reports, and correspondence with regulatory authorities
* Identify and mitigate regulatory risks associated with the spin-off process
* Communicate effectively with internal and external stakeholders, providing updates on project status and regulatory developments
* Provide regulatory guidance and training to cross-functional teams to ensure compliance and understanding of regulatory requirements
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