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.