北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京药品注册招聘

RA Project Manager-API

印度瑞迪博士实验室有限公司北京代表处

  • 公司规模:50-150人
  • 公司性质:外企代表处
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2022-06-29
  • 工作地点:北京-朝阳区
  • 工作经验:2年经验
  • 学历要求:本科
  • 职位月薪:2-2.5万
  • 职位类别:药品注册

职位描述

Responsibilities

1. Coordinate with the regulatory team based in India and translate the DMF shared from Indian office in regional language for submission as per the given timeline

2. Translate the amendment and annual reports that are shared by Indian office

3. Responsible for tracking of queries and letter of access issued to various customers

4. Coordinate and ensure the sample requirement from India to Regulatory authorities as per the timelines and maintain the tracker for the samples shared with agency.

5. Follow up the open issues for the new submissions and ensure the closure with the Indian regulatory team

6. Write the CDs DVD’s of the Applicant’s Part DMF and courier it to customers

7. Take up the administrative activities such as courier of the Applicant’s Part DMF, Letter of access, original declaration to customers and agencies and to India office

8. Follow up with the business team for the payment of the fee to the agents and agency.

9. Prepare the necessary presentations required for the department and organization

10. Maintain good knowledge in general/product specific scientific and regulatory requirement/ process.

11. Maintain strong working

Requirements:

1. Bachelor or Master Degree in pharmacy or related discipline.

2. 1-2 years of working experience in imported API registration/Relevant RA experience.

3. Familiar with requirement of procedure about DMF filling and registration testing issued in 2020.

4. R&D/Quality working experience is priority.

5. Good communication, quick learner. Experienced in MS office operation.

6. Good at English writing, reading and speaking.

7. Ability to handle multi-task activities.

职能类别:药品注册

公司介绍

Dr. Reddy’s, founded in 1984 and headquartered in Hyderabad, India. The company owns 21,000+ employees and is the second largest Indian pharmaceutical company in the world and one of the ***0 global generics companies. Dr. Reddy’s business spans Pharmaceutical Services & Active Ingredients (PSAI), Global Generics, Proprietary Products and Biosimilars, in 80 countries across the world.
Dr. Reddy’s has been developing business in China for over 20 years and is known as the *** multinational imported generics pharmaceutical company in the country. In 2000, we set up Kunshan Rotam Reddy Pharmaceutical Co Ltd as a joint venture involved in manufacturing, sales and marketing. In 2010, we established Dr. Reddy’s Laboratories Ltd (Beijing) Representative Office in China to manage regulatory affairs and import drug filing. In 2020, we set up WOFE Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited. and Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited Shanghai Branch to enable commercial related activities in China, as part of our expansion plan.

In Dr. Reddy’s China, all Reddy’s people pull together, trust and respect each other and work hand in hand. As a global enterprise, we provides our employees with a professional working environment with high-standard and strict requirements which makes our work more professional and reliable. We keep growing, and creating more opportunities for the future development, we provides a plentiful external training opportunities, upgrading employees’ skills, let each employee grow together with us.
As a family care about global health, we are here to share our knowledge and product to bring good health to China and the world.
瑞迪博士(Dr. Reddy’s)成立于1984年,总部位于印度海德拉巴,拥有21,000多名员工,是全球第二大印度制药公司、全球仿制药公司***0之一。瑞迪博士的制药服务和原料药,全球仿制药,专利药和生物仿制药业务遍及全球80个国家。
瑞迪博士在中国已经发展20多年,是中国***大跨国进口仿制药制药公司。2000年,我们成立了集生产、销售和市场于一体的合资企业昆山龙灯瑞迪制药有限公司,2010年,我们在中国设立瑞迪博士实验室(北京)代表处,进行进口药品注册申报事务,2020年,我们成立外商独资企业瑞迪博士(北京)药业有限公司和瑞迪博士(北京)药业有限公司上海分公司,在中国开展产品商业相关活动,这是我们业务扩张计划的一部分。
在中国,瑞迪人依旧齐心协力,彼此信任,尊重彼此携手前行。作为一家全球化的企业,为员工提供高标准严要求的专业工作环境,让工作更为专业可靠。瑞迪公司通过不断壮大,给未来发展创造了更多机遇,我们也为员工提供丰富的外部培训机会,提升员工技能,让每位员工和我们一同成长。
加入瑞迪,我们一起聚梦瑞迪,共塑健康世界!

联系方式

  • 公司地址:建国路91号金地中心A座