Taiwan Regulatory Submissions Coordinator job in Taipei

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This vacancy has now expired. Please see similar roles below...

Our client is a global, leading CRO that offers complete solutions across many therapy areas. They are looking to hire a Taiwan Regulatory Submissions Coordinator to join their team in Taipei, Taiwan.

Job Responsibilities:

Performs required activities within the country that lead to activation of investigative sites in all phases of clinical trials
Prepare, review, and file, under regulation, IND/CTA to Regulatory Agencies (MFDS) with global submission strategy
Communicate with global RSMs and RAs for the documentation required and support needed
Responsible for providing expertise in ethics and regulatory submissions, and review and finalization of essential documents required for site activation
Act as main contact for Ethical or Regulatory submission-related activities
Direct contact with sites during the study start process
Ensure submissions comply with applicable regulations and guidance documents
Advise sponsors on changing regulations and compliance requirements
Track submissions and ensure timely filing of documents

Role Requirements:

Bachelor's degree in the life sciences field or equivalent combination of education and experience;
At least one year of relevant working experience in CRO or Pharmaceutical Company
Experience in negotiating with Regulatory Agencies;
Excellent organization and communication skills;
Knowledge of Microsoft® Office;
Knowledge of ICH, MFDS, IRB/IEC and other applicable regulations/guidelines;
Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies;
Fluency in English and local language.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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