招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
-Support global regulatory affairs team to ensure timely initial and renewal submission of AMS manufactured products for China and as contract
manufacturer for APAC and CE.
-Support to respond to Authority inquiry or to resolve Authority issue,heath care and custom, in relation to AMS manufactured products
-Cooperate with global regulatory affairs team and AMS China regulatory affairs team in relation to change of products
-Support to marketing relative activity (Tender) in Roche affiliate
-Provide review, consultation and support to AMS project team in planning issues and regulatory opinions
-Support to define and execute regulatory strategy of AMS products
-Support an effective interface between respective disciplines of RDSL
-Impact assessment of new regulations and guidance from Chinese authorities
Main Tasks & Responsibilities主要工作职责:
1.Support registration of AMS products in Roche affiliates including CE Declaration– 30%
-Providing high quality documents according to EU IVD Directive and other local regulatory requirements regarding products initial and renew registration as well as change, and AMS as physical manufacturer registration to RDG CPS international team.
-Cooperation with global regulatory affairs and RDSL interfaces to define registration plan
-Collecting data and documents from RDSZ operations and quality, issuing statements to respond Authority inquiry or to marketing activities (tenders).
-Informing global regulatory affairs (Roche affiliate regulatory affairs team) about the AMS project plan and status
-Perform gap analyses on RDSZ submission files to decide on the use of existing documentation for submissions or to address the need for updating the documentation.
2.Support function within RDSZ – 50%
-Providing regulatory advice to AMS project team
-Keeping informed about global regulatory requirements. Introducing the ROW/EU regulatory requirements to respective disciplines within RDSZ and helping to implement the requirements into the RDSZ process
-Cooperation with AMS QM regarding the Notified Bodies Audit and ROW country Authority inspection or visits and manufacturer registration.
-Provide impact assessment for new regulations and guidance documents from Chinese authorities
3.Employee Leadership – 20%
-Initial training, leading and development of directly subordinated employees as per Performance Management and Succession and Talent Management procedures in regards to functional requirements and skills. Conduction one-on-one, assessment of training needs, salary adjustments, review of tasks as well as assignments and reassessment of further training needs with respect to skills, products, processes and regulatory requirements.
-Knowledge of Roche CPS products and documentation, know-how of the common processes in production, QM, QC and R&D within Roche
CPS. Know-how of CE Declaration process as well as detailed ROW regulatory requirements, particularly with APAC region.
Education& Qualifications教育背景与专业资格:
-University graduate (MSc) in one of the following fields: pharmacy, medicine, (bio-) chemistry, (molecular) biology, food and/or
biotechnology; ph.D. optional.
Experience工作经验:
-Well experienced in the field of international regulatory affairs
-Experience and proven skills in leading employees via successful leadership strategies, implementation of processes and structures, including
motivation and individual development of employees together with the implementation of restructuring processes
ProfessionalCompetencies/skills专业能力/技能:
-Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP.
-Experienced with the principles and system processes / tools within the regulatory field
-Experienced in dealing with all level of authorities including health care Authority and the Notified body and Custom etc.
-Experienced in analysis of regulatory processes, particularly with respect to compliance, efficiency and effectiveness
-Professional regulatory management with specific certification / degree
-Independent working style, well-experienced in organizational structures
-Proficient in communicating and presenting topics with business clientele
-Knowledgeable in statistics
-Experience with change processes within Roche CPS
-Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations
-Proficient language skills (written and spoken) in Chinese and English, German optional
-Competent with routine application of MS Office, SAP and other common office software, incl. databases and sharepoint
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