上海招聘

PSC Asia – Regulatory Affairs Specialist

Description

Assist and Recommend action in the coordination, compilation and submission of new drug applications, abbreviated new drug applications and Investigational new drug applications to the regulatory agencies.

Responsibilities
? Assist with activities concerned with the submission and approval products to government regulatory agencies.
? Provides guidance to project team members regarding regulatory compliance issues.
? Oversees the preparation and maintenance of regulatory submissions and files.
? Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
? Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products.
? Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
? Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
? Ability to review/approve of OTC product labeling for assigned brands, Company Core Data sheet development for assigned OTC ingredients, and SOP development/updates as required.


Requirements
? The candidate will have minimum of Bachelor's degree in relevant health-related scientific discipline, preference to advanced degree candidates with a R.Ph, or Pharm. D will be given.
? Must have a minimum of 7 years of pharmaceutical industry experience including previous experience with NDA, IND, and OTC Monograph products is required.
? Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment are required. Prior experience interacting with health authorities is required.
? The candidate will have the ability to work independently, manage several complex projects/issues in parallel, and effectively influence others in a cross-functional team setting with a solution-oriented and enterprise mindset.
? Mandarin, and English language a plus.

Due to highly responds, we will only approach to qualified candidates.

PSC生物技术(北京)有限责任公司在全球致力于推广和提升世界范围内医药和医疗器械行业的GMP水平，是全球高端GMP认证的引领者和传播者。 时至今日，美国医药服务有限已经成为全球首屈一指的专业化FDA、EMEA认证顾问公司，除美国洛杉矶总部外，相继在美国和世界其它城市成立分公司，以雄厚的技术力量覆盖全球，跻身成世界最具专业、最大的医疗行业咨询服务机构和原料药采购代理机构。公司从1996年成立至今，与北美、欧洲、亚洲的众多知名制剂企业建立了良好的合作关系，不仅为其旗下制剂、医疗器械产品提供验证及质量系统、国际认证、国际药政政策遵守等服务，更是囊括了产品进出口及采购和销售等多方面服务。

公司将为录用人才提供良好的职业培训，具有市场竞争力的薪酬福利待遇，有意者请发邮件至公司邮箱，并在Subject 栏注明应聘职位。


更多公司详情请参阅www.biotech.com或www.psc-asia.com

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

PSC Biotech has over 358 customers in 23 different countries around the world. PSC Biotech is organized into three primary Business Units:
1. Professional Services
2. Life Sciences Software and IT (Enterprise)
3. Life Sciences Hardware (Equipment and Instruments)
PSC Biotech has offices in North America, Asia and the Middle East. We are the world's largest specialty biotech life sciences consultancy.

Company provides competitive compensation and benefits to hired employees.

Know more about PSC, please enter www.biotech.com / www.psc-asia.com.