Regulatory Submissions Coordinator
ProClinical is working with a global, full-service Clinical Research Organization (CRO) active in over 40 countries across the globe. This company is seeking a Regulatory Submissions Coordinator to be based in Singapore on a permanent basis.
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials
- Prepare, review, and submit to Regulatory Agencies
- Communicate with global study teams and personnel on study progress
- Ability to effectively identify risks to site activations and mitigate as necessary
- Provide expertise and guidance to global study teams in ethics and regulatory submissions
- Review and finalize essential documents required for site activation
- Act as a main contact for Ethical and Regulatory submission-related activities
- Direct contact with investigative sites during the study start up and activation 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.
Skills and Requirements:
- Bachelor's degree in the science field or equivalent combination of education and experience
- Relevant working experience at a CRO, pharmaceutical company, or an investigative site
- Experience in preparing and submitting regulatory applications
- Excellent organization and communication skills
- Knowledge of Microsoft® Office
- Knowledge of ICH - GCP guidelines
- Knowledge of regulatory guidelines
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries
- Proactive approach to role with ability and willingness to learn and be challenged;
- Fluency in English
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.
R1215238 | EA13C686
A leading pharmaceutical company headquartered in the UK is seeking a Submissions Publisher to join their team in Sandwich, UK on a contract basis.