北京招聘

? Obtain successful registration of new products and be compliant and effective with all product safety activities.
? Manage and oversee all relevant maintenance activities potentially including LifeCycle Management strategy.
? Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
? Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
? Prepare, submit and support clinical trial applications including all related safety activities.
? Establish regulatory priorities or budgets and allocate resources and workloads.
? Develop and maintain standard operating procedures or local working practices.
? Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained.
? Maintain current knowledge of relevant regulations, including proposed and final regulations.
? Manage activities such as audits, regulatory agency inspections, or product recalls.
? Oversee the regulatory budget in the local affiliate.
职位要求：
? Pharmacy or Life Sciences qualification, or equivalent, with a minimum of 5 years prescription regulatory affairs experience. Licensed Pharmacist preferred.
? Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
? Ability to operate across a wide range of business activities and projects, including in-licencing and out-licencing projects
? Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
? Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
? Strong initiation and organizational skills
? Strong analytical skill and technical/ scientific competence
? Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
? Team-player, able to positively influence team members at all levels with a “can do” attitude
? Proactive, quick learner and independent worker

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。