Meet Life Sciences
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Our client is a growing biotechnology company focused on bringing transformative Rare Disease therapies to patients in need. They are seeking an experienced Regulatory Affairs CMC professional to drive global CMC strategy across late-stage and registration programs.
Candidate must be able to be on-site 5 days a week in Chicago, IL
Key Responsibilities
Lead the CMC regulatory strategy and authoring of high-quality submissions, including INDs, NDAs, MAAs, and lifecycle management activities. Own Module 3 preparation and review for investigational and commercial products. Provide regulatory guidance to cross-functional teams including Technical Operations, Quality, and Development. Serve as primary Health Authority contact for CMC topics and participate in global agency interactions. Ensure compliance with evolving global CMC regulatory requirements and maintain up-to-date knowledge of relevant guidance documents. Requirements
Bachelor’s, Master’s, or PhD in a scientific discipline. 8+ years of Regulatory Affairs CMC experience within the biotech/pharmaceutical industry. Proven experience preparing and submitting Module 3 sections and leading NDA filings. Strong understanding of drug substance and drug product manufacturing, analytical control strategy, and post-approval change management. Ability to thrive in a fast-paced, collaborative environment and manage multiple priorities. If you are interested in learning more, apply directly or reach out to kaitlyn.sumner@meetlifesciences.com for more information. Seniority level
Director Employment type
Full-time Job function
Science and Research Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Meet Life Sciences by 2x Get notified about new Director of Regulatory Affairs jobs in
Chicago, IL . Chicago, IL $155,000.00-$175,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Lead the CMC regulatory strategy and authoring of high-quality submissions, including INDs, NDAs, MAAs, and lifecycle management activities. Own Module 3 preparation and review for investigational and commercial products. Provide regulatory guidance to cross-functional teams including Technical Operations, Quality, and Development. Serve as primary Health Authority contact for CMC topics and participate in global agency interactions. Ensure compliance with evolving global CMC regulatory requirements and maintain up-to-date knowledge of relevant guidance documents. Requirements
Bachelor’s, Master’s, or PhD in a scientific discipline. 8+ years of Regulatory Affairs CMC experience within the biotech/pharmaceutical industry. Proven experience preparing and submitting Module 3 sections and leading NDA filings. Strong understanding of drug substance and drug product manufacturing, analytical control strategy, and post-approval change management. Ability to thrive in a fast-paced, collaborative environment and manage multiple priorities. If you are interested in learning more, apply directly or reach out to kaitlyn.sumner@meetlifesciences.com for more information. Seniority level
Director Employment type
Full-time Job function
Science and Research Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Meet Life Sciences by 2x Get notified about new Director of Regulatory Affairs jobs in
Chicago, IL . Chicago, IL $155,000.00-$175,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr