About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Prepare or maintain technical files as necessary to obtain and sustain product approval. Coordinate efforts associated with the preparation of regulatory documents or submissions. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. Qualifications 3 year working experience with a minimum of 2 years experience required in Regulatory, R&D or related area Minimum of 1 years experience preferred in pharmaceutical regulatory affairs. Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies. Biologics experience a plus. Experience in Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus Fluent English both oral and written Working Computer Operation skill Is willing to travel Experience working in a complex and matrixed environment is requiredDependent on individual aptitude Up to date knowledge of legislation Self motivated Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.