Regulatory Affairs

1 month ago

Cambridge, Canada Virbac Full time

Within our Canadian business, this role will support overall Project Management; Labeling Projects Management and Post Approval Regulatory Support of Virbac’s new and existing products. You will use advanced project management skills to keep projects on time, provide milestone updates and improve business processes. A Senior Specialist applies advanced knowledge of the job area typically obtained through advanced education and work experience. They will manage projects/processes, be expected to work independently and the problems faced may sometimes be complex requiring cross-functional engagement.

Key areas of responsibilities include:

• Working with the project DRI (Directly Responsible Individual) and relevant Canadian and US functions delineate the optimal path, plans and time to market for the assigned Product; give visibility to internal stakeholders (Leadership, RA, QA, Manufacturing) on the main milestones.

• On a project-by-project basis act as the DRI for Labeling requests – from the decision to start a graphic label or an LCM change to the handover of the approved up to the finalization of the Change Control by QA.

• Support post approval work (RA & QA) for the Canadian office, create methods for up to date GMP compliance of FPLT manufacturing sites for FDF/API, alignment of RA/QA activities and documentation, ensure a timely and efficient Change Control process.
 

Required and Desired Characteristics:

 • University or Bachelor’s degree in a technical field, preferably scientific or Project Management designation

• 3-5 years experience working in pharmaceutical, biological, medical device, or pesticide industries with reference for regulatory/quality assurance requirements and methods

• Exposure to graphic design applications to support labeling a plus

• We are seeking strong analytical decision makers, who are able to think critically and communicate clearly to an extended audience

You will have a strong focus on New Product Launches (NPL), and drive LCM (Life Cycle Management) activities including labeling changes and enhancements and post approval activities as required by our internal Regulatory Affairs and Quality Assurance departments.

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