北京招聘

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

·       The BioPharma Specialist/ Sr. Specialist is responsible for DMF filings of excipient/API in local language with regulatory authority in China

·       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 DMF 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/ Sales 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 BioPharma internal audits.

·       Performs other duties as assigned to support Local regulatory

 

QUALIFICATIONS (Education/Training, Experience and Certifications)

·        Science education or equivalent in BioPharma or BioChemistry

·        5+ years of experience in regulatory affairs field especially DMF registrations

·       A proven track record of connecting local authorities and completing certain local regulatory issues

 

KNOWLEDGE, SKILLS, ABILITIES & COMPETENCIES (Those necessary to achieve conformity of products and services)

·       DMF registration with CDE, China

·       Proven experience in BioPharma/Pharma

·       Experience in Pharmaceutical industry, 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

 

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.