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.