Manager – Regulatory Affairs (17711)

Positions: 1 Total Experience: 8 – 16 years POSITION TITLE: Regulatory Affairs Manager / Senior Manager FUNCTION: This position responsible for implement Key CFDA registration projects, make RA strategy for product line and also manage other stuff like promotional materials review, standard compiling, product labeling, local-test designs, data analysis, documents submission related to CFDA registration, progressive regulatory strategies of DMFs and Drug Product applications. BASIC PURPOSE OF THIS POSITION: Manage regulatory activities to get DMFs and drug products registered timely in CFDA to align with business need. To contact internal and external stakeholders to gain necessary files of DMFS / drug products, to compile product standard for key product and complete entire registration process. ESSENTIAL DUTIES AND RESPONSIBILITIES: The incumbent will also be responsible for, but not limiting to the following duties: Provide strategic and technical regulatory input and support to line manager to contribute for decision making on DMFs & drug development / filing strategy and license maintaining strategy to deliver the highest value to business. Independently compile high quality filing document complying with external and internal requirement to provide right and clear drug profile and data to CFDA to obtain CFDA certificates / approvals in a reasonable timeline. Responsible for all registration projects includingtranslation of documents from English to Chinese and vice a versa. Receive and Prepare the list of supplementary documents during the Bundle Technical Review and prepare final supplementary dossier, submission to CDE, etc to obtain application approval with DMF status “A”. Independently engage with internal and external stakeholders to follow up every milestone closely to ensure issue identified, escalated, resolved timely and target filing, and approval timeline plan is achieved. Co-ordinate between us and local authorities like CDE for sample import and transfer to identified testing lab. Ability to provide strategic regulatory guidance to support post-market activities. Establish and maintain a good relationship with key regulatory authority in daily work such as CFDA, CDE, NIFDC, CPC, etc via professional communication. Develops comprehensive understanding of CDE regulations and guideline and applies that knowledge to enhance probability of Regulatory success and enhancing Regulatory compliance throughout development and the commercial life cycle Make sure line manager is fully informed about DMFs / drug products registration status in daily work. Support line manager on budget planning and monitoring in daily work. Provide timely and high-quality regulatory support and input to internal key stakeholders such as R&D, QA, QC, medical, commercial, and manufacturing sites as needed. Need to have frequent meetings with global team out of working time. Ensure timely and flawless implementation of company SOP and compliance requirement in daily work. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: A minimum of bachelor’s degree in chemistry or biological or pharmacy Minimum 8-10 years’ experience in regulatory affairs field.

• Should have required qualification/licenses necessary for carrying out the regulatory work. Proven ability to communicate (written/oral) with various functions and with authority. Fluency in English Ability of cross functional co-operation. Strong ownership and cross boundary working mindset A strong capability in problem solving Strong ability of lobby, influence, and negotiation.