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IQVIA
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Reg Affair Officer

Reg Affair Officer

IQVIA

5 years

0 Lacs

bengaluru karnataka india

Posted:1 day ago| Platform:

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Skills Required

database compliance tracking initiation documentation vault management training inspection support research healthcare development

Work Mode

On-site

Job Type

Full Time

Job Description

Role Summary:
We are seeking a qualified Regulatory Affairs Project Coordinator and manage outsourced local regulatory affairs activities across multiple international markets. The role involves coordinating regulatory submissions, artwork workflows, database updates, and compliance tracking, ensuring alignment with global standards and internal SOPs.Key Responsibilities:Regulatory Operations

Manage artwork workflows in designated systems, including initiation, validation, and closure tracking.
Coordinate sample ordering and documentation for import authorization.
Update regulatory databases and portals with submission and approval data.
Handle deviations, CAPA tracking, and documentation per internal quality procedures.

Required Qualifications:

Bachelor’s or master’s degree in pharmacy, Life Sciences, or related field.
5+ years of experience in Regulatory Affairs, preferably in international or outsourced settings.
Strong understanding of regulatory submission processes and lifecycle management.
Familiarity with regulatory tools such as Veeva Vault RIMS and artwork management systems.
Experience with SOPs, CAPA management, and KPI tracking.

Training & Compliance

Ensure all team members are trained on relevant tools and procedures.
Maintain updated training logs and CVs for inspection readiness.
Support continuous training and competence development.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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IQVIA

Pharmaceuticals / Biotechnology

Durham

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Reg Affair Officer