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Senior Executive / Assistant Manager Regulatory Administrative Services

Getz Pharma · Karachi Division, Sindh, Pakistan

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Position SummaryThe Sr. Executive / Assistant Manager will be responsible for evaluating the business needs of local and international markets and executing documentation-related activities to ensure smooth product launches.Key ResponsibilitiesPlan and manage all activities related to the Dossier Sample Submission Plan for regulatory countries as per the approved planner.Facilitate the Regulatory team in executing change alerts related to product induction and product changes, along with their tracking.Plan and execute code-opening procedures for Raw Materials, Packaging Materials, Semi-Finished Goods (SFG), and Finished Goods (FG) for new and renewal product development.Plan and execute the initiation of PV forms against new product development and change management programs.Facilitate the Regulatory team in P.R.-related matters, including the arrangement of development samples, vendor payments, and other essentials required for dossier submissions.Support departmental objectives and regulatory compliance initiatives.Eligibility CriteriaBachelor’s / Master’s degree.Expertise of SAP S/4Hana module is required.A minimum of 4-6 years of relevant work experienceRequired Knowledge & SkillsGood understanding of GMP processes and SOPs.Proficiency in change alert handling and P.R. execution.Proficiency in SAP and related activities.Strong written and verbal communication skills.Proficiency in MS Office, particularly Microsoft Word and Excel, for routine tasks.