Associate Director, Regulatory Affairs CMC and Devices at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Regulatory Affairs CMC and Devices in United States.

This role is a key regulatory leadership position within a clinical-stage biotechnology environment focused on advancing innovative biologic therapies for complex immune-mediated diseases. The Associate Director, Regulatory Affairs CMC and Devices is responsible for driving the preparation, coordination, and execution of global CMC regulatory submissions that support clinical development programs across multiple assets. You will play a critical role in ensuring compliance with evolving global regulatory expectations while enabling timely progression of clinical trials. This position requires close collaboration with technical operations, quality, and cross-functional regulatory teams, as well as external partners, to deliver high-quality, submission-ready documentation. You will also contribute to shaping regulatory strategies for drug-device combination products and supporting interactions with global health authorities. Operating in a fast-paced, science-driven environment, this role demands both deep technical expertise and strong cross-functional coordination skills to ensure regulatory excellence across multiple programs.

• Plan, coordinate, and deliver global CMC regulatory submissions, including INDs, amendments, IMPDs, CTAs, and annual reports supporting clinical development programs.
• Author and review Module 2 and Module 3 content, including quality summaries, drug substance and drug product sections, stability data, and comparability assessments.
• Prepare and support responses to health authority questions related to CMC and device/combination product topics across FDA, EMA, PMDA, and other global agencies.
• Contribute to regulatory strategy and documentation for drug-device combination products, including device technical files and integrated submission content.
• Execute CMC and device regulatory strategies in alignment with regulatory leadership to support clinical trial progression and late-stage development goals.
• Collaborate closely with Technical Operations, Manufacturing, Analytical Development, Quality, and external partners to ensure accuracy and consistency of regulatory documentation.
• Support preparation for health authority meetings, including briefing packages, submission materials, and presentation content.

• Bachelor’s degree in a scientific or related field with 6+ years of experience in CMC regulatory affairs within clinical-stage biologics development.
• Proven hands-on experience authoring late-stage INDs and amendments, including full ownership of CMC sections and supporting documentation.
• Strong understanding of global regulatory frameworks, including FDA, EMA, ICH guidelines, and relevant device regulations.
• Experience with biologics and drug-device combination products such as prefilled syringes or autoinjectors; familiarity with companion diagnostics is a plus.
• Demonstrated ability to prepare high-quality responses to regulatory agency questions during clinical development.
• Excellent technical writing skills with the ability to communicate complex scientific and regulatory concepts clearly and accurately.
• Strong organizational and project management skills with the ability to manage multiple submissions under tight timelines.
• Proficiency with regulatory document management systems (e.g., Veeva RIM, eCTD publishing tools).
• Strong interpersonal and collaboration skills across cross-functional and external teams.
• High attention to detail and ability to thrive in a fast-paced, evolving biotech environment.

• Competitive compensation package including base salary ($175,000–$195,000) and performance-based bonus eligibility
• Equity grant opportunities as part of long-term incentive program
• Comprehensive health, dental, vision, and retirement benefits
• Unlimited paid time off and two annual company-wide shutdown periods
• Remote-friendly work environment with regular in-person collaboration opportunities
• Strong focus on professional development and career growth
• Opportunity to contribute to innovative therapies in a high-impact biotech setting
• Inclusive workplace culture that values diverse perspectives and backgrounds