上海招聘

Title: Associate, Regulatory Affairs

职位： 药政专员

Reports To: Senior Director, Regulatory Affairs

Basic Functions:

To provide regulatory affairs and GMP support for new products and process improvement projects, including drug master file submissions and ANDA dossier registrations. Work with cooperated firms to review and approve information and documents for submission, file and maintain the submissions. Support the regulatory inspections from regulatory authorities.

Location:
Shanghai based; up to 20% travel throughout China.

Education/Work Experience:

§ Minimum bachelor degree in pharmaceuticals, chemistry, biochemistry or microbiology

§ At least 3 years registration/GMP experience for submissions to FDA/EU authorities.

§ Good knowledge of current registration requirements as well as FDA/EU trends and guidelines.

§ Work experience on APIs or sterilized products is preferred.

§ Good communication and interpersonal skills.

§ Good organizational and project management skills to coordinate multiple projects.

Principal Accountabilities:

§ Provide guidance, support and technical assistance in all aspects of registration and GMP operations to cooperated firms.

§ Provide regulatory affairs support during customer and regulatory audits and inspections of the facilities.

§ Review and approve all documentation supporting submissions

Specific Technical/Job-Related Skills:

§ Good knowledge of current registration requirements as well as FDA/EU trends and guidelines.

§ Possesses strong organizational skills for prioritizing workload and responsibilities.

§ Strong written communication, interpersonal, negotiations and problem solving skills are required.

§ Proficient with PC-based word processors, databases and spreadsheets.

Histar (Shanghai) Co., Ltd. (HISTAR) provides world-class quality Active Pharmaceutical Ingredients at an excellent value, in full compliance with standards required by leading regulatory agencies in the USA and Europe. In partnership with state-of-the-art manufacturers, HISTAR offers a wide range of Active Pharmaceutical Ingredients, Pharmaceutical Intermediates, as well as Finished Product Licensing, Custom Manufacturing and Outsourcing services. The HISTAR GMP Compliance & Regulatory Affairs Group provides exceptional technical support and efficient regulatory documentation preparation to manufacturers throughout the world.

With rapid business growth in China, Histar (Shanghai) Co., Ltd. is seeking experienced and qualified candidates for the following positions

The interested candidates please send your resume both in English and Chinese to hr@H3LS.com.
 

宇科（上海）医药科技有限公司（HISTAR）是一家著名的外商独资医药科技咨询公司，提供符合美国FDA及欧洲EDQM认证的世界级优质药品原料。HISTAR会同全球著名的生产厂商，为客户提供广泛的药品原料、半成品，以及产品的认证、定制和采购服务。HISTAR的GMP及药证部门还为全球的药品生产商提供专业的认证技术支持、高效的认证相关文件的准备等服务。

随着公司业务在中国的快速发展，HISTAR现需招募以下人员


应聘者请发送简历至：hr@H3LS.com