Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
Post : Regulatory Start Up Associate II
Brief Position Description
The Regulatory Start Up Associate II is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval.
Responsibilities
• Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
• Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
• May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards, and other local authority related activities.
• Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.
- Ensure submission packages are accurate and complete per local requirements.
- Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.
- Follow submission, application to approval.
• Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required.
Candidate Profile
• Graduate in a clinical, pharmacy or life sciences related field.
• At least 1-2 years Regulatory Start-up experiences in a CRO.
Additional Information
Experience : 1-2 years
Qualification : Graduate in a clinical, pharmacy or life sciences
Location : Bengaluru
Industry Type : Pharma
End Date : 20th July, 2023
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