上海招聘

Role: Regulatory Affairs-China Market

具有1-3年法规事务经验，熟悉中国药品注册相关法规

Job Responsibilities

• Preparation, review, submission, query responses and secure approval of different products for the China market.

• Well-versed with the pre-submission and submission activities of NMPA/CDE for different products.

• Manage registration document packages. Ensure accurate and timely preparation of regulatory submissions of products, amendments and maintenance of existing registration to obtain timely approval of product registration from NMPA.

• Manage regulatory and registration activities products in china market.

• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.

• Support the development and analytical functions in the regulatory issues start from project kick-off to the final submission.

• Review and analyze R&D, technical, regulatory data, as well as enquiries from marketing, business and trade related to Regulatory.

• Provide regulatory guidance, consultation, interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements.

• Maintain good communication with regulatory agencies/institutes (e.g., CFDA, CDC) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing to facilitate and expedite regulatory approvals.

• Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.

• Follow NMPA regulations and analysis impacts to business/pipeline or responsible products.

• Take charge of new products launch in China, including make strategy, control registration timeline,, prepare registration documents, following evaluation and get approval

Skills:

• Master’s degree or above in  pharmacy/life sciences/bio

• 2-5 years in RA experience or in relevant area.

• Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines.

• Good communication skills

• Complete Product registration for china market

        

普霖贝利生物医药研发（上海）有限公司创建于2009年9月。公司主要从事高端制剂的研究开发及制剂产品的注册，并同时与欧美知名药厂就药物研发进行战略合作共同研发药物。目前，科研主攻方向为化学药物的制剂研发，药物类型为抗心血管病、抗抑郁症、抗糖尿病、抗肿瘤及抗艾滋病药等。未来，公司将开展全方位的产品研发。

电子邮箱：hr_pb@prinburybiopharm.com