Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Consultant to support regulatory strategy and international submissions for drug-led combination products with a strong device constituent focus. The consultant will provide expertise in device regulatory strategy within pharmaceutical/biotechnology submissions, including bridging strategies for device changes, risk management, and design control considerations. The role will focus on supporting international regulatory submissions outside the United States, particularly in the Asia Pacific (APAC) and Latin America.

This is a part-time consulting role, approximately 5–15 hours/week for a few months.

Responsibilities

• Support regulatory strategy for the device constituent of drug-led combination products in international submissions
• Develop and justify international regulatory strategies for submissions outside the United States, including APAC and Latin America
• Support device bridging strategies where the same drug is used with different device constituent parts (e.g., vial to autoinjector)
• Review device-related technical documentation within drug-led submissions, including compatibility, integration, and usability considerations
• Serve as a secondary reviewer for CTD Module 3, with a focus on device-related and supporting CMC content
• Support responses to non-U.S. Health Authority inquiries related to device integration, risk management, and technical issues
• Contribute to risk management and design control activities, including review of Design History Files (DHF), Risk Management Files (RMF), and related documentation
• Collaborate with internal and external stakeholders to ensure alignment of device regulatory strategy across regions

Qualifications

• A bachelor’s degree in a scientific discipline is required.
• 5+ years of Regulatory Affairs experience within pharmaceutical or biotechnology organizations; combination product experience required, with a focus on device constituents.
• Demonstrated experience supporting device aspects of combination products, particularly within drug-led submissions
• Experience with international regulatory submissions, especially APAC and/or Latin America
• Understanding of medical device regulatory expectations as applied to combination products
• Working knowledge of risk management, design control, and quality principles, including ISO 14971 and ICH Q8/Q9
• Experience reviewing regulatory documentation; primary authorship not required
• Exposure to CMC and CTD Module 3 content
• Familiarity with Pharmacokinetics/Pharmacodynamics (PK/PD) concepts
• Experience with ISO 13485 and device quality systems

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at

Equal Opportunity Employer Minorities/Women/Veterans/Disabled