Execute material management activities related to product inventories, materials, and supplies for LFB-USA, as well as management and oversight of shipments involving LFB group companies or third parties (contractor to contractor). Regularly interacts with colleagues and external parties at various levels including senior management. Implements and follows established policies, procedures, methods and evaluation criteria for obtaining results. Ensures stock materials are ordered and in-stock to meet company requirements while maintaining acceptable inventory levels. Coordinates the efficient movement of materials with collaboration of Supply Chain, Operations, Purchasing, Quality Control/Assurance and Veterinary Services. Works with Operations and Quality Assurance/Control to develop purchasing specifications for relevant materials. Ensures shipping practices are consistent with regulatory requirements and are performed with validated methods where required.
The Director/Associate Director Regulatory Affairs will be proactive in providing strategic direction in the implementation of quality strategies, policies, procedures and optimal infrastructure to ensure systems are aligned with company submissions, LFB Corporate Quality, and applicable external regulatory authorities. This person/position will work closely with a number of LFB France groups providing guidance and expertise. This person/position may be asked to represent or participate in LFB for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).
The Manager, Regulatory Operations reports into the Senior Program/Project Manager of Regulatory Affairs who has global purview within the organization. The Department of Regulatory Affairs oversees units of Medical/Scientific Writing and Pharmacovigilance and interfaces closely with Clinical and Manufacturing departments. This position is pivotal in maintaining organization’s direct lines of communication for, interactions with, and access to Regulatory Authorities/Agencies in the US and abroad. The individual who fills this role should enjoy a multi-cultural work environment with colleagues in the US and abroad. Strong regulatory operations, eCTD, and submission technical capabilities are required. Flexible work from home options!