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Post: Drug Regulatory Affairs Business Franchise/Regulatory Coordinator (RC)
Job Description:
The Regulatory Coordinator is responsible for providing operational regulatory and compliance support to the DRA global program team representative and/or GTAL on development projects/major line extensions through development, registration, and approval including post approval commitments.
Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database (DRAGON).
Timely preparation of all DRAGON information updates and compliance reconciliation reports in accordance with established procedures and related timelines.
Subject Matter Expert for regulatory compliance activities and supporting tools (for example, 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
• Support EudraVigilance/EVMPD activities
• Support the GPRD/GPRMs as necessary to coordinate the development of components of Module #1 in the CTD
• Support the GPRD/GPRMs as necessary in the compilation and co-ordination of reviews of Briefing Books for regulatory Health Authority meetings
• 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)
• Responsible for updating and maintaining QPPV tracker
• Additional support for team communications on planning and logistics for Health Authority Meetings
• 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
* 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 Queries
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Candidate Profile:
Drug Regulatory Affairs BF/BU Regulatory Coordinator
Education/and/or Bachelors Degree preferred professional experience: Languages: Fluency in English as a business language
Experience/ Professional Requirements:
DRA Regulatory Coordinator:
• Minimum of 1-2 years pharmaceutical experience and/or a minimum of 1-2 years of regulatory experience
• Prior publishing/Regulatory Operations experience desired
• 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/projects
Additional Information:
Experience: 1-2 Years
Location: Hyderabad
Education: Any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 104986BR
End Date: 3rd Oct, 2012
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