Post: Senior Regulatory Affairs Associate (Labeling)
Job Description:
We are seeking a highly skilled and experienced Senior Regulatory Affairs Associate specializing in labeling for our dynamic team. The ideal candidate will have a significant background in drug development, with a focus on labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Key responsibilities include:
- Labeling Regulations Expertise: Demonstrate a strong working knowledge of key labeling regulations/guidance, with a proven track record in label development, including CCDS, USPI, and packaging.
- Comparator Labeling: Research and create comparator labeling documents to ensure compliance and accuracy.
- Annual Reports: Possess a robust understanding and past experience in creating annual reports, contributing to regulatory compliance and reporting.
- Collaboration with Tech Ops: Ability to collaborate effectively with Technical Operations for seamless artwork implementation.
- SPL Proficiency: Showcase proficiency in Structured Product Labeling (SPL), covering all aspects, types, and troubleshooting. Manage the review and approval of labeling in a document management system.
- Electronic Document Management: Experience in using electronic document management systems and/or electronic submission, ensuring efficient regulatory processes.
- Life Cycle Management: Contribute to Life Cycle Management activities, particularly 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
If you are a dedicated regulatory affairs professional with a strong background in labeling and a passion for contributing to the development of new drugs, we invite you to apply. Join our team and play a pivotal role in shaping the regulatory landscape in the pharmaceutical industry.
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