北京Sr. Regulatory Affairs Manager招聘_萌蒂（中国）制药有限公司招聘Sr. Regulatory Affairs Manager

Sr. Regulatory Affairs Manager

专业要求：

学历要求：本科及以上

工作经验：不限

薪资待遇：面议

招聘人数：1

招聘对象： 社会人才

我要投递简历

更新日期：2020-07-09

有效期：长期有效

年龄要求： 不限

外语要求： 不限

提供食宿：

工作地点： 北京

1. Develop and implement registration plan for new products in China within relevant therapeutic areas. 2.Manage registration submissions for new products registration and clinical trial applications.3.Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.4. Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.5. Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support. 6. Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.7.Closely follow up regulation changes and analyze/predict its impact on company registration strategies.8. Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation. 9. Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.任职要求：1. Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.2.Ability to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.3.Understanding of market access needs and implementation of appropriate measures for health care purposes.4. Strong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.5. Ability to anticipate and facilitate issue resolution to meet local registration requirements.6.High leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.7.Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering high quality results and strives for continuous improvement. 8. A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.

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北京萌蒂制药有限公司（Beijing Mundipharma Pharmaceutical Co.,Ltd）是萌蒂/耐普/普渡独立联合公司和北京制药厂于1993年9月共同投资创建的生产特殊镇痛药品的中外合资制药企业，并于2006年成为萌蒂/耐普/普渡独立联合公司的独资公司。公司采用萌蒂/耐普/普渡独立联合公司下属英国公司NAPP公司、美国PF公司的制药技术，生产高科技含量的控、缓释剂产品，服务于中国市场；同时秉承了萌蒂/耐普/普渡独立联合公司致力于人类健康、发展、和平的崇高宗旨，通过不断的努力改善中国疼痛患者的生活质量，同时也履行着对社会、对国家的回报。根据世界卫生组织制定的三阶梯止痛治疗原则，公司率先在国内推出了治疗重度、中度、轻度疼痛的药物。自1995年，公司一直是北京市先进技术企业；2005年初，公司再次通过了国家药品监督管理局的GMP认证。公司致力于推动中国人民健康事业的发展，不断引进、推广和创新药品，向医生和患者提供技术先进、品质卓越的产品，为改善中国疼痛患者的生活质量进行不懈努力。同时，公司也致力于在公司内部营造一个激励创新的环境，把以人为本，诚信道德作为企业的最高宗旨，使员工能够充分施展自己的才华，向医生、患者提供技术先进，品质卓越的镇痛药品，实现改善疼痛患者的生活质量，回报社会的目标。