Project Manager, CMC Regulatory Affairs

Project Manager, CMC Regulatory Affairs Aleon Pharma International, Inc. (Aleon), headquartered in Parsippany, New Jersey, is a consulting firm dedicated to providing global regulatory affairs, clinical development, pharmacovigilance, and quality and compliance services. For more than 15 years, our experienced team has worked closely with innovative sponsor companies and offered solutions tailored to each client's individual requirements. As a result, our clients expedite their product development and reach patients sooner to ultimately save more lives. · Best Workplaces Honoree - National top 3% for employee engagement · Best Workplaces – National top 5% for employee engagement · Outstanding Employer Award by New Jersey Business & Industry Association Job Type: Full-time Job Responsibilities: · Lead regulatory affairs projects, including formal meetings with the FDA, Investigational New Drug (IND) applications, NDAs/BLAs (New Drug Applications / Biologics License Applications), Orphan Drug Designation (ODD) applications, expedited program applications, and more from project initiation to project completion. · Manage the preparation and review of CMC documentation, ensuring every submission meets FDA and other health authority requirements and industry standards. · Serve as the primary FDA interface for your projects—facilitating productive meetings, crafting responses, and building trusted agency relationships. · Drive projects forward and coordinate IND, NDA, BLA, and related FDA filings, transforming complex data into clear, compelling regulatory narratives. · Partner with CMC leadership to shape the regulatory strategy — surfacing risks early and charting the most efficient path to approval. · Own the plan: scope, timelines, cross-functional orchestration, and reporting for assigned programs—keeping execution on track and outcomes visible. · Stay ahead of the curve: monitor evolving FDA regulations and guidances, distill implications, and deliver concise regulatory impact analyses that inform decision-making. Qualifications: · Ph.D. or Masters degree in Biochemistry/Molecular Biology or Chemistry (medicinal/pharmaceutical/organic/analytical chemistry or related fields). · 1-3 years’ experiences in CMC regulatory affairs preferred. We are willing to train exceptional candidate(s) who can demonstrate quality and potential. Skills and Requirements: · Exceptional attention to detail and excellent organization skills. · Excellent interpersonal, written, and oral communication skills. · Creative and open-minded. · Proactive and passionate desire to learn. What We Offer: · Aleon offers competitive compensation with many benefits, including paid time off, 401(k), health and life insurance, and much more. · Aleon has a dynamic and flexible working environment where professionals dedicated to learning can truly thrive. · Limitless learning possibilities, and fantastic career advancement opportunities. · Friendly and positive work environment. · Dynamic company culture where employees are engaged and motivated. We are confident that you will find that Aleon is a very rewarding and exciting place to work. If you feel that you are a good fit for this position, email your resume with confidence to [email protected]. Aleon Pharma International, Inc. is an equal opportunity employer. Candidate must be authorized to work in the US. Job Type: Full-time Pay: $80,000.00 - $100,000.00 per year Benefits: • 401(k) • 401(k) matching • Dental insurance • Health insurance • Paid parental leave • Paid time off • Parental leave • Retirement plan • Vision insurance Work Location: Remote Apply tot his job