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Responsibilities: In this role, you will be responsible for all local regulatory affairs lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following: ? Variations (Administrative, Labelling, CMC, Safety, dossier harmonization) ? Preparation and submission of application dossier hard copy paper and/or electronic (CD, Web-based) ? Update Local PI (label and packaging components) (including labeling translation where local language is required ? Review advertising / promotional material against approved label ? Renewals ? Annual reports ? Issue Management (e.g., PQSC Quality, safety issues like out-of-stock situation management, DHCPL preparation coordination & submission in accordance to local regulations & company SoPs, representing RA in related internal committees) ? Regulatory Intelligence for the portfolio in scope ? Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities ? CTA (Clinical Trial Applications for Established Products) (where applicable) ? Parallel Import check of goods (where applicable) ? Global regulatory team participation for selected established portfolio products ? Primary contact for Local Health Authority on delegated products ? Leads project delivery teams: ? Ensuring the project team is onboard and aligned to the project expectations ? Ensuring business requirements are defined with precision & quality, driving execution and delivery ? Create a motivating & inspiring environment, foster innovation, ideas and quality Requirements: ? Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry. ? Mandatory Knowledge of China regulation and well adheres of Chinese and English language ? Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously ? Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables ? Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions ? Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process. ? Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures Key Attributes ? Enthusiasm & confidence ? Adhere to our principles and values. ? Time Management skills.