Sr. Specialist, Regulatory & Product Compliance
威达优尔贸易（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：贸易/进出口
职位信息
- 发布日期：2020-10-19
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：2年经验
- 学历要求：本科
- 职位类别：药品注册 其他
职位描述
?Responsible for legal tracking, vigilance, regulatory guidance and regulation interpretations that impact the business.
?Keeps informed of regulatory regulations & changes.
?In cooperation with other stakeholders, he/she implements the necessary changes to maintain company compliance, including SOPs & instructions, and registrations when required.
?Give input and work together with Product Management and OEM to secure compliant products are placed on the market.
?Provide professional support on expert subject to customers and internal stakeholders on request.
?Collaborate and support Local QA for customer-facing activities.
?Work collaboratively across functions/sites to support Customer inquiries as required and QA / Regulatory agreements to protect our business and that compliance/customer requirements are established properly.
?Performs Regulatory Product Compliance internal audits.
?Performs other duties as assigned.
?Local Regulatory Affairs is the local contact with authorities (participating on inspections, declarations & reporting, licenses requests)
?Investigate queries with local authorities
?Local Legal requirements / Legislation follow-up and update of Central team
?Provide inputs for suppliers product range introduction if local legislation to consider
?Support for central projects with local implementations
?Ensure that local organisation is compliant with the Legal requirements / Legislation
?Suspect customers / transactions to raise to Central team & authorities
?Provides Regulatory support to the local Business and Operations Teams
?Ensure that all local licenses with regard to distribution agreed product portfolio are available from Avantor.
?Check and approve license/EUD sent by customer and coordinates with Central REGA for unblockings
?Authority to block deliveries
?Communicate and up-date Central REGA on all local activities (inspections, up-date in legislation, license requirements,...)
?Ensure the interface with RA Academy (Training program)
?Interact with the local Departments (QM, Sales, Customer Services, Logistics,...) and with the Central Departments (Central REGA, Chief Scientist, QM/QA, ....) as well as with local Customers and Authorities.
Knowledge, Skills, Abilities and Competencies:
?Science education or equivalent in Chemistry, Pharma or BioChemistry
?2- 6 years of experience in chemical, lab or Pharma industry
?Experience in Lab Supply or equivalent experience required at a minimum
?Need an awareness of regulations / legislations
?Ability to analyse, interpret regulatory requirements and define necessary solution driven actions
?Ideally experience in Product Compliance regulations and interpretation, including FDA regulations, Local Legislation, IPEC Guidelines, Drug Quality, cGMP,GDP, GLP, GDocP and applicable Pharmacopeias.
?Excellent Analytical skills
?Strong interpersonal skills
?Must have excellent Communication and good planning skills
?Must be Customer oriented and Results driven
?Open minded and team player in a multicultural environment
?Ability to develop innovative strategies and creative solutions within the regulatory context
?Ability to work independently and complete individual projects with minimal supervision
?Good organizational skills and proven ability to manage multiple projects in a high-pressure environment toward timely completion
?Extended computer skills, SAP would be an advantage
?Fluent in English
公司介绍
Avantor is a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.
联系方式
- 公司地址：朝阳区东三环中路20号 乐城中心