Role Overview

We are seeking an experienced Pharma Export Compliance & International Trade Consultant to advise clients on international trade regulations, pharmaceutical export control laws, and compliance best practices. The ideal candidate will have a deep understanding of pharmaceutical trade policies, licensing requirements, and regulatory frameworks. This role involves providing strategic guidance, managing documentation, and ensuring that clients adhere to global export laws while expanding into new pharmaceutical markets.

Key Responsibilities

• Regulatory Compliance: Ensure clients adhere to international trade laws, pharmaceutical export control regulations, and country-specific health authority requirements (e.g., US FDA, EMA, CDSCO, MHRA, WHO-GMP).
• Export Licensing & Documentation: Assist in obtaining necessary export licenses, preparing certificates of pharmaceutical products (COPP), and ensuring compliance with country-specific documentation requirements.
• Strategic Trade Advisory: Provide insights on pharmaceutical market entry strategies, international trade agreements, and regulatory frameworks.
• Risk Management: Identify and mitigate risks related to international pharma trade, customs regulations, and compliance issues.
• Good Distribution Practices (GDP): Guide clients in adhering to GDP and Good Manufacturing Practices (GMP) regulations to ensure product integrity in transit.
• Pharmaceutical Trade Agreement Utilization: Advise clients on leveraging Free Trade Agreements (FTAs) and preferential trade agreements to optimize costs and expand their market reach.
• Collaboration with Authorities: Liaise with government agencies, drug regulatory bodies, and customs officials to ensure smooth export operations.
• Monitoring & Reporting: Keep clients informed of changes in pharmaceutical export laws and update internal compliance policies accordingly.

Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, International Business, Regulatory Affairs, or a related field.
• 5+ years of experience in pharmaceutical export compliance, international trade consulting, or regulatory affairs.
• In-depth knowledge of pharmaceutical trade laws, including WHO-GMP, FDA, CDSCO, EMA, and other global health authority regulations.
• Experience with pharmaceutical export licensing, customs procedures, and controlled substance compliance.
• Familiarity with Free Trade Agreements (FTAs), bioequivalence requirements, and international shipping regulations.

Required Skills

• Analytical Thinking: Ability to interpret complex pharmaceutical trade regulations and provide actionable recommendations.
• Problem-Solving: Expertise in identifying pharma compliance risks and implementing effective solutions.
• Client Communication: Strong ability to explain regulatory requirements clearly to clients in the pharmaceutical industry.
• Attention to Detail: Precision in managing pharma export documentation and compliance processes.
• Negotiation & Diplomacy: Ability to liaise with regulatory authorities and international partners effectively.
• Project & Time Management: Strong organizational skills to handle multiple pharma export engagements simultaneously.

Preferred Experience

• Experience working with customs brokers, regulatory agencies, or pharmaceutical trade associations.
• Prior consulting experience in pharmaceutical trade compliance or export strategy.
• Certification in pharma trade compliance (e.g., RAC, CUSECO, CTCS, or similar credentials).

Benefits & Perks

• Competitive salary with performance-based incentives.
• Comprehensive health and wellness benefits.
• Career growth opportunities in a global pharmaceutical consulting environment.
• Professional development programs and industry certifications.
• Flexible work arrangements and a collaborative team culture.

Join Us:

If you have a passion for global pharmaceutical trade, regulatory compliance, and helping businesses expand internationally, we invite you to apply and contribute to our clients’ success.

How to Apply:

Send your resume and cover letter to info@sharpadv.com