潍坊招聘

Position: Drug Regulatory Affairs Specialist (药政法规事务专员)

Job Purpose:
Registration for API and FDF including import product and local produced product registration; ensuring legitimacy of promotional materials of company

Job Description:
-- Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op)
-- Coordinate the patent search and confirm the administration and new drug protection in Chi-na
-- Review registration dossiers, to ensure registration documentation to confirm the requires of SFDA
-- Initiate and confirm translation of dossiers for all documents received into Mandarin (or into English) through project team review
-- Ensure registration documentation, samples submission and process to related government department
-- Be the key players in clearance and review of all promotional materials to ensure legitimacy of the materials.
-- To be a specialist of Chinese drug regulatory and provide update information on regulatory requirements of SFDA
-- To build relationships with officers and departments of SFDA to ensure approval procedure within set timelines
-- To be a good coordinator for 3rd researching company
-- To translate key technical documents on the registration dossiers

Job Requirements:
-- University degree in the life sciences (medicine, Pharmacy, bio-sciences), graduate degree in Pharmaceutics or Medicine is preferred
-- 5+ years board multi-functional experience in pharmaceutical development process and science, specifically in regulatory, clinical or chemistry
-- Good English both verbal and written
-- Good communication skill internally/externally

有意者请将中英文简历发送到：dimeng.han@novartis.com

关于诺华山德士

山德士，诺华集团非专利药业务部门，是全球非专利药行业的领导者。山德士提供约1100种国际品质、亲民价格的非专利药。山德士拥有约26000名员工，业务遍及全球约140个国家，在生物仿制药、注射剂、眼科药物和皮肤科药物领域名列全球榜首，在吸入剂领域排名全球第五。山德士的主要产品系列包括抗生素、治疗中枢神经系统紊乱、胃肠道、心血管疾病的药物和激素类药物。除了以上药品，山德士还开发、生产和销售药物活性成分、生物活性成分及抗感染药物。近年来，山德士业务强劲增长，并进行了一系列的收购，包括斯洛文尼亚的莱柯、加拿大的Sabex、德国赫素、美国Eon Labs、奥地利的依比威制药公司、美国Oriel Therapeutics和Fougera制药公司。2012年，山德士全球销售额达87亿美元。