Require Regulatory Submissions Coordinator at Medpace

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries.

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 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 clinical trial applications
• Experience in negotiating with Regulatory Agencies;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office;
• Knowledge of ICH, 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
Experience : 1 year
Qualification : B.Sc
Location : Navi Mumbai
Industry Type : Clinical research
Functional Area : Regulatory Submissions
End Date : 31st July, 2018