Regulatory Affairs
4 weeks ago
Regulatory Affairs & Project Management Senior Specialist (Canada) page is loaded Regulatory Affairs & Project Management Senior Specialist (Canada) Apply locations Cambridge, Canada posted on Posted 4 Days Ago job requisition id R2482
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
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.
Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension. Joining Virbac means joining dynamic teams ambitious for success. Add Your Talent to Ours Get in touchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match
About UsFocusing on animal health, from the beginning
At Virbac, we provide innovative solutions to veterinarians, farmers and animal owners in more than 100 countries around the world. Covering more than 50 species, our range of products and services enables to diagnose, prevent and treat the majority of pathologies. Every day, we are committed to improving animals’ quality of life and to shaping together the future of animal health.
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