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Drug Regulatory Affairs Specialist
Drug Regulatory Affairs Specialist-March 2024
Taipei City
Mar 31, 2026
About Drug Regulatory Affairs Specialist

  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.

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