Support supervisor in managing end-to-end coordination for all US, EU projects.
Interact with vendors and internal teams (Analytical, Formulation, Regulatory, QA/QC) to resolve technical concerns (documents, analytical issues, material quality).
Ensure requirements are met for regulatory submissions and regulatory agency deficiencies with respect to Raw material / packaging material.
Vendor & Material Management
Support vendor qualification activities including technical questionnaires, DMF gap assessments, and follow-ups where applicable.
Arrange technical documents to R&D team requirements.
Resolve ARD/QC technical issues, Regulatory & Quality requirement by liaising with raw material vendors.
Handle complaints related to raw material quality in coordination with QA and vendors.
Prepare, update, and maintain centralized technical procurement databases (vendor details, material specifications, regulatory status, change history, risk assessments).
Understand the impact of changes in raw material processes/specifications, prepare change controls, and coordinate with internal teams for timely closure.
Commercial & Logistics Support
Prepare purchase orders and coordinate with logistics for inwarding concerns.
Track shipments against orders and update internal teams routinely.
Coordinate with finance for pending payments against orders.
Manage order processing of API, excipients, impurities, and reference standards, ensuring timely delivery.
Support responses to regulatory queries/deficiencies related to raw and packaging materials under guidance of Regulatory Affairs
Compliance & Continuous Learning
Stay updated with ICH guidelines and FDA requirements.
Present key regulatory updates internally on a routine basis.
Key Competencies
Technical Knowledge: Strong understanding of pharmaceutical raw materials, packaging, and regulatory requirements (FDA, ICH).
Coordination & Communication: Excellent ability to liaise with multiple stakeholders, both internal and external, ensuring clarity and timely resolution.
Problem-Solving: Proactive in identifying issues and driving effective solutions with vendors and internal teams.
Adaptability: Quick learner with the ability to grasp technical concepts and adjust to evolving regulatory requirements with aptitude to manage multiple projects simultaneously.
Reliability & Integrity: Demonstrates diligence, dependability, and professional conduct in all responsibilities.
