连云港招聘

Your Tasks and Responsibilities:


The primary responsibilities of this role, are to:
· Collaborate with country regulatory teams to set up global regulatory strategy of assigned projects;
· Lead and coordinate worldwide regulatory input into the country/regional/global development plan of assigned projects;
· Involve actively in decision making on all key development questions via an assessment on the probability of regulatory success;
· Represent International RA on assigned global project teams;
· Interact with the country regulatory team to support the conduct of global trials and registration of new products. Drive and/or support country IND/CTA and NDA/BLA applications. Guide the review process, check for accuracy, scientific consistency, compliance to country and global regulations and completeness of submission;
· Support preparations for meetings and teleconferences with health authorities;
· Assess the impact of new regulations, guidelines or enforcements and advise the broader regulatory group on requirements to maintain compliance with regulatory operations activities;
· Set up and optimize certain regulatory systems and processes to support globalization acceleration;
· Conduct regulatory due diligence on potential in-licensing and out-licensing opportunities;
· Supervise regulatory staff to provide leadership and career development inputs as well as coaching/mentoring support;
· Foster collaborative, efficient, and effective working relationship with internal and external colleagues;




Required Qualifications:


· Bachelor of Science with at least ten years of experience in biomedical activities of which at least five years including country/global regulatory experience or Master of Science with at least eight years of experience in biomedical activities of which at least three years including country/global regulatory experience or Ph.D. or D.V.M. or Pharm. D. in Life Sciences with at least six years of direct experience in biomedical research, of which at least one year include country/global regulatory experience in related therapeutic areas;
· Knowledge of the country/regional/global regulations and guidelines including ICH, EMA and FDA guidelines;
· Excellent communication skills, verbal and written, and strong analytical skills;
· Demonstrated leadership and project management skills;
· Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners;
· Experience working with clinical research and regulatory teams based in USA/Europe/APAC.




Preferred Qualifications:


· Experience in therapeutic areas: Oncology, Autoimmune, Cardiovascular, Metabolism, Pain, and Anti-infection.




Location:


· All over the world, prefer Shanghai/Beijing/Hangzhou China.

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内***的抗肿瘤药和 手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。 恒瑞医药在连云港、上海、成都、苏州、南京、美国、日本、澳大利亚等地均设有研发中心和分支机 构，目前各类研发人员1800多人，其中有1000多博士、硕士、及海归人士，有5人被列为国家“***”，7人被列入“江苏省高层次创新人才引进计划”，公司 雇员超过17000人。
上海盛迪医药有限公司是江苏恒瑞医药股份有限公司的全资子公司，公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积14000平方米。上海盛迪作为恒瑞新药研发的重要组成部分，下设临床医学、中央医学事务、中央市场、临床前开发、新药协调、商务发展、转化医学、对外研发合作等核心职能。