Role Purpose: To provide strategic and technical regulatory CMC support to line manager for the purpose of commencing and maximizing GSK China Rx business by facilitating the CMC submission and approval in a timely and high quality manner. Key Accountabilities/Responsibilities: Provide strategic and technical regulatory CMC input and support to line manager to contribute for decision making on drug CMC development strategy and license maintaining CMC strategy to deliver the highest value to business. Independently compile high quality CMC filing document complying with external and internal requirement to provide right and clear drug profile and data to NMPA to achieve targeted labeling and drug features to be approved. Independently engage with internal and external CMC stakeholders to follow up every CMC milestone closely to ensure issue identified, escalated, resolved timely and target CMC filing and approval timeline plan is achieved. Establish and maintain a good relationship with key CMC regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc via professional communication. Make sure line manager fully informed CMC projects registration status in daily work. Support line manager on budget planning and monitoring for CMC projects in daily work. Provide timely and high quality CMC regulatory support and input to internal key stakeholders such as medical, commercial and GSC site as needed. Significantly contribute or lead function continuous improvement initiative Ensure timely and flawless implementation of company SOP and compliance requirement in daily work. In charge of all RA CMC relevant activities of new products (IND/CTA/NDA) and established products (Variation and renewal), including CMC strategy making and implementation, CMC document preparation, CMC technical review follow up, HA communication for CMC topics, QC testing, GMP on-site inspection, ChP, etc.0202 Qualifications/Requirements: A minimum of bachelor degree in Chemistry or biological or pharmacy Minimum 8 years experience in regulatory affairs field and at least 3 years in MNC 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 Ability to coordinate, influence and lead people or a virtual team
