Research Associate

The Importation and export specialist supports Pharmaceutical and Medical Device R&D operations by managing the importation/export of research materials, medical devices, samples, and equipment. This role ensures that all import/export activities comply with applicable regulations, customs requirements, and internal quality standards, enabling uninterrupted R&D, and validation activities.

Key Responsibilities

Import/Export Operations & Logistics

• Coordinate end‑to‑end importation/export of R&D materials, including APIs, excipients, reference standards, medical devices, components, and lab equipment as applicable.
• Prepare and manage import/export documentation such as invoices, packing lists, certificates of analysis, MSDS, and permits as applicable.
• Actively track shipments, manage delivery timelines, and resolve delays or discrepancies.
• Coordinate international shipments with freight forwarders, customs brokers, and logistics providers.
• Ensure proper classification (HS codes), valuation, and country-of-origin determination for all shipments.

Regulatory & Compliance Management

• Ensure compliance with applicable import/export regulations and guidelines, including:
• Indian Customs, CDSCO requirements
• FDA, EU MDR, ICH, and ISO requirements as applicable
• GxP (GMP, GLP, GDP) standards
• Obtain and maintain required licenses, NOCs, and approvals for R&D and imports.
• Collaborate with Regulatory Affairs and Quality teams to ensure imported materials meet regulatory and quality standards.
• Prepare and review import/export documentation such as:
• Commercial invoices, packing lists
• Import licenses, NOCs, permits
• Pro-forma invoices for R&D and non-commercial shipments

Vendor & Stakeholder Coordination

• Liaise with customs brokers, freight forwarders, vendors, and government authorities.
• Partner with R&D scientists, engineers, and procurement to understand material requirements and timelines.
• Support supplier qualification and documentation activities as applicable.

Documentation & Record Management

• Maintain accurate import/export records, logs, and approvals in line with audit and inspection requirements.
• Support internal and external audits by providing documentation and compliance evidence.
• Ensure proper archiving and traceability of import‑related/export related records.

Risk & Issue Management

• Identify and mitigate risks related to delays, regulatory changes, or compliance gaps.
• Proactively address customs queries, inspections, and holds.
• Escalate critical issues and propose corrective actions.
• Stay current with changes in global trade, customs regulations, and pharmaceutical/medical device requirements.

Required Qualifications

• Bachelor's degree in pharmacy, Life Sciences, Engineering, Supply Chain, or a related field.
• 3–7 years of experience in importation/export or trade compliance within Pharmaceutical or Medical Device environments.
• Strong knowledge of customs regulations and import licensing for R&D and clinical materials.
• Familiarity with GxP, FDA, CDSCO, ISO 13485, and ICH guidelines.
• Experience working with customs brokers and logistics service providers.
• Excellent organizational and documentation skills.
• Knowledge of cold‑chain logistics and controlled substances handling.
• Experience with ERP or trade compliance systems.

Key Skills & Competencies

• Regulatory & Trade Compliance
• Import/Export Documentation & Licensing
• Stakeholder & Vendor Management
• Attention to Detail
• Problem Solving & Risk Mitigation
• Time & Priority Management
• Communication & Coordination