Internship: Regulatory Affairs

Overview:

Our Regulatory Affairs Internship Program is designed to provide students with practical exposure to product registration, import/export processes, and delivery performance monitoring. Interns will gain hands-on experience in dashboard creation, lead time analysis, and proof of delivery tracking, while developing analytical and operational skills essential for modern supply chain management.

Objectives:

• Provide interns with practical knowledge of product registration and the fundamentals of regulatory affairs processes
• Strengthen coordination and communication skills through close stakeholder managment.
• Ensure timely product registration and approval with the FDA in accordance with internal timelines
• Ensure that product description and classification is accurate and true

Key Responsibilities:

• Regulatory Compliance & Submissions – Prepare, review, and submit accurate regulatory filings, maintain documentation, and ensure timely renewals in line with local and international regulations.
• Process & Audit Management – Organize regulatory records, manage document control, and support internal/external audits and inspections, implementing corrective actions when needed.
• Cross-Functional Collaboration – Work closely with R&D, QA, Clinical Affairs, and Marketing teams to align regulatory strategies and act as liaison with regulatory agencies.
• Pharmacovigilance Oversight – Establish and maintain local PV systems, ensure timely reporting of adverse events, and coordinate safety monitoring with global PV teams.
• Safety Compliance & Communication – Monitor evolving drug safety regulations, conduct training, manage audits, and serve as primary contact for urgent safety-related inquiries and communications.

Learning Outcomes:

By the end of the program, interns will:

• Understand the fundamentals of product registration.
• Gain practical experience in communicating and coordinating with the FDA.
• Gain an in-depth understanding of FDA standards and regulations, ISO standards, and global regulatory requirements
• Acquire insights into how regulatory product registration affects and contributes to business goals.

Candidate Profile:

We seek a motivated individual who is:

• In their 3rd – 4th year

• Enrolled in any of the following courses:

• BS Pharmacy

• BS Chemistry

• BS Biology

• BS Medical Technology

• BS Chemical Engineering

• Any healthcare-related course

• Analytical with strong problem-solving and technical skills.

• Detail-oriented with proficiency in data visualization and reporting.

• Interested in developing expertise in logistics, supply chain monitoring, and operational efficiency.

Note: We are looking for student interns who are seeking to complete their school mandated OJT requirements since we will have to establish an MOA with the respective schools.