10.0 - 15.0 years

0 Lacs

karnataka

On-site

The primary responsibility of this role is to develop a Labeling Strategy for health authority interactions and address labeling queries from Health Authorities or Country Organizations related to assigned programs/products. This includes ensuring proper Artwork Management for activities such as Initial Submission and Commercial Launch in coordination with the Cross-Functional Team. Additionally, you will be responsible for reviewing Promotional Materials and participating in Cross-Functional Team meetings to provide Regulatory input on strategic decisions and ensure compliance with regulations to avoid any misleading information. You will also be tasked with coordinating with External Vendors to prepare and review Translation documents that support Global Regulatory Submissions. Furthermore, the role involves preparing SPLs for Initial Submissions, Labeling Responses, and Drug Listings for Approved Products within specified timelines. You will be involved in managing the change management process for CCDS, Non-CCDS, and Annual reportable labeling changes, as well as analyzing competitor information for regulatory policy and labeling projects. In this position, it is essential to escalate, notify, and resolve any issues that could impact the final labeling submission. You will be required to maintain an internal tracker for CCDS, Non-CCDS, and Annual reportable labeling changes and submissions. Additionally, managing Global Labeling Impact Assessment, including RLD updates and Safety Information Updates, is part of the responsibilities. Leading and guiding the Labelling Team members to adhere to business processes and ensure high-quality deliverables is also a key aspect of this role. The ideal candidate should hold a degree in Pharmacy or Science with a minimum of 10 to 15 years of experience in the Global Labelling domain. Preferred skills for this role include adherence to project specifications, effective time management, proactive identification of label issues, deep understanding of quality and compliance, and the ability to communicate complex issues clearly. The role also involves people management activities such as hiring, training, mentoring, and performance appraisals. Demonstrating flexibility to adapt to changing priorities, balancing multiple tasks, and mentoring junior staff are also important aspects of this position. Overall, the role requires a proactive and detail-oriented individual with excellent organizational skills and a strong focus on compliance and quality in Global Labelling operations.,

Posted 1 week ago

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