Senior Regulatory Affairs Associate (Labelling)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• Must have  4-6 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
• Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
• Strong knowledge of US, EU, Switzerland, Canada and, Australia regulatory labeling lifecycle management
• The ability to research and create comparator labeling documents.
• Strong understanding and experience creating annual reports.
• The ability to collaborate with Tech Ops for artwork implementation.
• Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
• Managing label updates, compliance, and governance.
• Electronic document management systems use and / or electronic submission experience.
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
• Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
• Monitor, manage and control artwork changes.
• To manage and maintain the Artwork Trackers & Systems.
• To ensure artwork PDF’s are maintained and latest versions are readily available.
• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved
• Experience with consumer advertising and educational materials
• Experience in handling Veeva, TVT, Docubridge etc.