Reg Affair Officer

2 weeks ago

Bengaluru Karnataka, India IQVIA Full time

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.

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