Regulatory Affair-Lead/Sr/Jr

Sevagan

KRG Technologies Inc.

25000 | Avenue Stanford | Suite 120 | Valencia, CA 91355

Direct Phone: (661) 367 8000 Ext. 513 | Email: sevagan @ krgtech.com

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

All your information will be kept confidential according to EEO guidelines.