PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Regulatory Affairs Associate (Labeling)
Job Description
• Relevant 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)
• The ability to research and create comparator labeling documents
• Strong understanding and past 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.
• Electronic document management systems use and / or electronic submission experience
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions
Additional Information
Location : Hyderabad, Telangana, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory / Consulting
End Date : 20th March 2024
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