Associate Director, Regulatory CMC

Job not on LinkedIn

🕒 August 26

🇺🇸 United States – Remote

💵 $175k - $200k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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👻 Ghost score 20%

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs under the direction of the Senior Director • Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements • Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams • Support health authority interactions, including briefing documents and information request responses • Maintain regulatory compliance for CMC activities supporting clinical and commercial supply • Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers • Manage external consultants, CMOs, CROs, and regulatory vendors

🎯 Requirements

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline; 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience • Technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines, such as formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality • Ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies • Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions • Strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages • Experience supporting small molecule drug products • Experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred • Demonstrated leadership of complex CMC regulatory activities, including health authority interactions • Ability to influence cross-functional teams, build consensus among technical SMEs, and work effectively with external manufacturing, testing, and other development partners • Ownership mindset with a proactive, can-do attitude and strong commitment to excellence • Strong project management, organizational, written, and verbal communication skills • Ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment • Proficiency in leveraging AI tools and other digital technologies for document preparation, review, data analysis, and day-to-day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns