Sevagan
KRG Technologies Inc.
25000 | Avenue Stanford | Suite 120 | Valencia, CA 91355
Direct Phone: (661) 367 8000 Ext. 513 | Email: sevagan @ krgtech.com
Job Description
Skills Required:
· Working in close collaboration with the Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process
· Develop/adopt & implement best practices for producing & maintaining high quality deliverables
· Liaising with a team of Publishers located globally. Working in a global capacity with colleagues across these regions
· Providing strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EU, US)
· Ensures country-specific regulatory requirements, as provided by client, are assimilated into teams and processes. Establishes new processes including documentation and perform QC work through spot checks, as needed.
· Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of Regulatory affairs
· Provide inputs as a SME to operations team as and when required
· Monitor the quality of deliverables, identify potential risks and mitigate them in advance and raises concerns and issues to the Engagement Manager proactively.
Experience:
· Good Clinical Practice (GCP)
· 21 CFR part 11
· Excellent verbal & written communication
· Ability to prioritize work
· Experience in Regulatory Affairs in Pharmaceutical/ biologic/ Chemical Products/ Medical Devices
· Knowledge of regulatory and in specific regulatory publishing tools like eCTDXpress, ISI toolbox, firstdoc (document management system), Insight publisher
· Regulatory Affairs Certification preferred
· Submissions Management and dossier preparation experience for US and EU region with format like CTD/eCTD/NeeS as per country-specific requirements
Additional InformationAll your information will be kept confidential according to EEO guidelines.
Skills Required
- Experience in Regulatory Affairs in Pharmaceutical/ biologic/ Chemical Products/ Medical Devices
- Knowledge of regulatory publishing tools like eCTDXpress, ISI toolbox, firstdoc (document management system), Insight publisher
- Regulatory Affairs Certification
What We Do
Established for more than two decades, KRG Technologies, Inc., headquartered in Valencia, CA, is a distinguished leader in Workforce Solutions, Microsoft Technology Solutions & Services, and Edge Computing (iOT) across the USA, Canada, Dubai, and India. Recognized as a Great Place to Work for two consecutive years, and a five-time honoree by Inc5000, and certified with ISO 9001 and 27001, KRG Technologies has demonstrated a steadfast commitment to excellence and innovation in the Information Technology & Services industry. KRG specializes in providing all-around workforce solutions, developing advanced digital applications, Microsoft solutions, and Edge Computing(iOT) for smart spaces. Well-known for getting things done, we focus on finishing work on time and sticking to the budget without sacrificing quality. We are good at making cost-effective solutions that not only meet but go beyond what the client wants, making sure everything goes smoothly and gets the best results. The purpose of KRG’s existence is ‘employment creation’ and we want to have long-term relationships with our employees and clients. To do this, we follow the important principles of being honest and transparent. We offer customers the advantages of: • Software development processes - flawless execution and project management. • Leveraging a combination of proven onsite and offshore • Professional Services Unit to augment your onsite team capacity/capability • Commitment to meet your objectives "on time - within budget" • Aggressive Pricing & Proven Track Record.
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