Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team! Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Post : Regulatory Submissions Coordinator
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 and 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; and
- Track submissions and ensure timely filing of documents.
Candidate Profile
- Bachelor's degree in the science field or equivalent combination of education and experience;
- At least one year of relevant working experience in CRO or Pharmaceutical Company;
- Experience in preparing and submitting MFDS clinical trial applications
- 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
Additional Information:
Location: Navi Mumbai
Education: B.Sc
Industry Type: Pharma/biotech/Clinical research
Functional Area: Clinical Operations
End Date: 22nd November, 2017
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