Ready to Shape the Future of Drug-Device Combination Products?

Are you a seasoned regulatory expert with a keen eye for detail and a passion for bringing life-changing treatments to patients globally? Imagine a pivotal role where your unique expertise directly influences the development and successful launch of innovative drug-device combination products. At name, a prominent leader in biotechnology, we're seeking a Senior Regulatory CMC Drug-Device Combination Product Lead. This is an unparalleled opportunity to steer global regulatory strategies, ensure compliance, and truly make a difference. Your work will be highly visible across the organization, directly contributing to our mission of delivering groundbreaking therapies. This is a fully remote, worldwide opportunity, allowing you to contribute from anywhere.

Overview

As our Senior Regulatory CMC Device and Combination Product Lead, you will hold a critical position, providing essential device and combination product regulatory expertise. Your insights will be crucial in supporting the development and implementation of global regulatory strategies, ensuring the clinical and commercial success of our key assets. This full-time role offers significant visibility and impact, collaborating with cross-functional teams, leading important regulatory submissions, and helping to develop processes that advance our business objectives. Your contributions will directly enable name to maintain its leadership in biotechnology and deliver innovative treatments to patients across the globe.

Key Responsibilities

Actively represent the Regulatory CMC Device function on diverse cross-functional teams, providing expert regulatory guidance for both combination products and medical devices.
Lead the authoring and coordination of complex regulatory documentation and submissions, always ensuring meticulous compliance with global health authority requirements.
Develop and implement robust global regulatory strategies for new and existing drug-device combination products throughout their lifecycle.
Serve as the primary regulatory contact for health authorities on device and combination product-related matters, fostering strong communication channels.
Provide strategic input and regulatory oversight for device design controls, risk management, and quality systems.
Collaborate closely with R&D, Quality, Manufacturing, and Commercial teams to integrate regulatory considerations seamlessly into product development plans.
Contribute to the continuous improvement of internal regulatory processes and policies, enhancing efficiency and effectiveness.
Monitor and interpret evolving global regulatory landscapes, particularly concerning device and combination product regulations, and advise internal stakeholders accordingly.

Requirements

A strong scientific or technical background, typically evidenced by a relevant Bachelor's degree; advanced degree preferred.
Significant experience in regulatory affairs within the pharmaceutical or medical device industry, with a substantial focus on drug-device combination products.
Deep expertise in global regulatory requirements for medical devices and combination products, including FDA (e.g., 21 CFR Part 4, 820), EMA, and other international standards.
Proven ability to lead and manage complex regulatory submissions (e.g., INDs, NDAs, BLAs, PMAs, 510(k)s, CE Mark filings) and interact effectively with health authorities.
Exceptional analytical, problem-solving, and decision-making capabilities.
Outstanding written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to diverse audiences.
Demonstrated leadership qualities, including the ability to influence cross-functional teams and drive consensus in a matrix environment.
While specific years of experience were not detailed in the original job listing, a senior-level professional in this field typically possesses extensive experience.

What You'll Gain

Joining name as a Senior Regulatory CMC Drug-Device Combination Product Lead means stepping into a role with immense impact. You will gain unparalleled visibility within a leading biotechnology company, directly influencing the trajectory of innovative therapies. We offer a challenging yet rewarding environment where you can continuously grow your expertise in a rapidly evolving regulatory landscape. You will collaborate with brilliant minds across various disciplines, expand your professional network, and most importantly, contribute to bringing life-changing treatments to patients worldwide. Your efforts will directly underpin both the clinical and commercial success of our key assets, making a tangible difference in global health outcomes.