Regulatory Coordinator Job Openings in Hyderabad, Telangana - Global Drug Development Recruitment 2018


Global Drug Development Careers 2018 - Global Drug Development give an opportunity to fill Regulatory Coordinator that will be placed in Hyderabad Telangana. You will receive much better probability in addition to less dangerous are living later on. Becoming a member this corporation can make and individual capable of accomplish your purpose simpler in addition to assist your current dream be realized.

To help make this business eye-sight and mission happens legitimate; Global Drug Development can be open pertaining to brand-new position as begin as February 2018. Everyone who is enthusiastic about filling up this vacanct, remember to engage in this Regulatory Coordinator recruitment inside . It can be encouraged for everyone players to get ready most important requirements for this task recruitment procedure, for the reason that method need you to definitely allow acceptable spec that this business desires because of this place. If you are that you will be the one which may fill up the standards, you can try to see more information about Regulatory Coordinator Job Opening below.

Global Drug Development Recruitment 2018

Regulatory Coordinator Job Opening in Hyderabad Telangana

Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database (DRAGON). -Subject Matter Expert for regulatory compliance activities and supporting tools (eg DRAGON) providing support to DRA PIE in a matrix reporting environment to ensure HQ and CPO compliance with internal procedures governing health registration management, compliance reporting and HA commitment data management activities. -Provides support for internal/external inspections. -Provide support as needed for Routine Health Authority submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc. and act as main liaison with DRA Operations to ensure accurate and timely submissions to HAs. -Manage and execute drug shipping ticket review process (US). -Support EudraVigilance/EVMPD activities - Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions - Assist in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables including responses to Health Authority queries) - Support update of QPPV tracker - Provide operational support for obtaining up-to-date Regulatory Intelligence and other regulatory support Information Review Support the GPRD/GPRMs to ensure: Timely delivery of Safety Labeling change submissions Timely delivery of Routine Health Authority submissions Timely completion of Drug Shipping Process (US). Provide support for DRA responsible part of Pharmacogilence compliance Timely completion of Module #1 in the CTD Timely completion of briefing books for regulatory Health Authority meetings Timely delivery of IND/IMPD and NDA/MAA/CTD to Health Authorities Regulatory deliverables met (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables) Timely delivery of Regulatory Intelligence and other regulatory support information Completion of submissions to Health Authority
Minimum requirements Bachelor Degree Fluency in English as a business language Minimum of 1-2 years pharmaceutical experience and/or a minimum of 1-2 years of regulatory experience •Good communication and negotiation skills •Proactive personality •Fast and flexible, focused on timely delivery and stretch targets •Ability to plan and priorities workload •Ability to work in a matrix environment •Ability to build effective relationships across teams •Prior publishing/Regulatory Operations experience desired

As one of the leading company in United State, Global Drug Development offers variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Global Drug Development also gives a dynamic work environment in order to encourage employees to contribute optimally, and at the same time is able to escalate new experience and knowing through the company programs.

If You fascinated to apply Regulatory Coordinator Hyderabad Telangana February 2018 Global Drug Development Global Drug Development, immediately prepare requirements / files and documents needed for fill Regulatory Coordinator Hyderabad Telangana February 2018 Global Drug Development above. To apply by online, please click the "Apply" button below. If you still do not satisfy with our job recruitment information above, you can try to read other job recruitment information that we provide in our website which still located in Hyderabad Telangana region from any other company.

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