Senior Associate - CMC5 job opportunity at ClinChoice.

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ClinChoice Senior Associate - CMC5
Experience: General
Pattern: full-time
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Regulatory Affairs

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degreeGeneral
loacation Bengaluru,, India
loacation Bengaluru,....India

Primary Responsibilities: Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval. Responsible for writing CMC modules – 2 & 3. Exposure to EU & CIS region in Regulatory filings Manage and coordinate product life cycle management. Ensure regulatory compliance with local regulatory requirements. Foster and maintain professional relationships with the health authorities. Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary. Maintain regulatory work processes and tracking tools that improve performance levels and transparency. Promote regulatory intelligence in both local and regional initiatives. Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area. Responsible for reviewing CMC modules. Execution of regulatory strategies (local and regional) in line with business plan. Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met. Ensure to adherence to timelines and quality set parameters. Review of Formulation, generation of ingredient list and Claims as per set standards. Compilation and review of labeling components as per SOP. Qualifications and desired skills: Minimum B.S. Chemistry, Pharmacy or related scientific field Experience in CMC regulatory affairs for pharmaceutical products. Experience in Module 3, Module 2.3 and relevant Module 1 e-CTD documentation Ability to multi-task effectively and work independently in a remote setting Attention to detail Excellent written and verbal communication skills Project management skills Familiarity with EU pharmaceutical guidelines and their interpretation  

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