The Position

　　Responsible for clinical trial related submissions to Health Authority by closely collaborating with local Clinical Operation team and Corp to ensure complying with company SOP and ensure that the company's compliance is in line with relevant regulations.

　　Handle and support Regulatory Affairs related activities and other occasional assigned matters.

　　Task & Responsibilities:

　　[Clinical Trial application]

　　Clinical trials related submission and coordination, including:

　　Clinical trial dossier submission

　　Supplementary submission

　　Amendment application

　　Document management, tracking, electronic filing for the clinical dossier

　　Contact person between Health Authority and local/global stakeholders

　　Regulatory compliance review/evaluation

　　Review and validate the clinical dossier provided by CO team

　　Maintain regulatory and related databases of Boehringer Ingelheim

　　Provide the instruction to CRO/CO team for preparing the submission-required documents

　　[Regulatory Operation]

　　Advertisement application per market team’s requests to city government

　　Raise concerns with the Functional Lead as appropriate

　　Organizing meetings

　　Monthly RA meeting

　　Quarterly cross-functional meeting

　　Archive related documentations

　　Corporate CRC / CCDS / others and TW HA official letter e-dispatch to TA RA and/or archive records

　　Requirements:

　　Master degree, major in biology, pharmacy or chemistry or life science-related

　　Over 2-3 years regulatory submission experience

　　Interpersonal and communication skills

　　Extremely detail oriented, well organized, and work well under pressure. Stronglearning ability

　　Ready to Contact Us?

　　Please contact our Recruiting Team: TW : +886-225129622; [email protected]

　　Position Area

　　Regulatory Affairs

　　Position Area

　　Taiwan, Taipei

　　Organization

　　TW – Boehringer Ingelheim Taiwan Ltd

　　Schedule

　　Full time

　　All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.