CMC Regulatory Affairs Specialist - Remote

Make an impact. Build a career.

At Pace, we're committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you'll hear the same thing repeated again and again: we work here because what we do positively impacts the world.

If you're curious, driven and inspired by the idea of doing important work with real-world impact, there's no better place to build your career.

Find your place at Pace

Join us as a CMC Regulatory Affairs Specialist, where you'll put your love of science to work in the Scientific Insourcing Services department. You'll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace.

The CMC Specialist will utilize their experience to assist in the preparation and review of documents for submission to the FDA, including formal FDA meeting requests and briefing packages, CMC components of investigational new drug (IND) applications, related progress reports, and amendments, and expedited approval programs. The CMC specialist will also perform regulatory strategy and gap analyses of clients' materials to assess their needs as they move their drug through clinical development to marketing approval. The CMC specialist is expected to provide detailed feedback and advice into applications where clients have gaps or questions in their CMC methodology which may result in a clinical hold from the reviewing agency.

Note: Postion is Remote

Note: This is an evergreen posting for future positions with Pace. If you would like to be considered during the next round of hirings and have the qualifications, please apply.

What you'll do

Prepare various FDA applications and documents, including but not limited to formal meeting requests and briefing packages and CMC components of INDs
• Review clients' CMC program to identify critical gaps and provide regulatory strategy for the best path forward
• Write regulatory strategy reports to help clients move their drug through clinical development to marketing approval
• Prepare expedited approval program applications for submission to FDA and other regulatory agencies, including orphan drug designations, fast track designations, and breakthrough therapy designations
• Ensure the content and structure of documents meet all established regulatory requirements
• Communicate with the assigned FDA project manager regarding submissions, questions, and/or issues with application
• Communicate effectively with clients via teleconference meetings to develop regulatory strategy and establish timelines
• Perform content and formatting level Quality Control (QC) for internal review of documents written by other colleagues
• This position involves a hybrid work environment (2 days/week working from home and 3 day/week working in the office)

What you'll bring

• MS in chemistry or other related scientific discipline, PhD preferred
• 3-5 years of relevant pharmaceutical and regulatory experience with drugs and/or biologics, 5-7 years preferred
• Knowledge of regulatory requirements, including International Council for Harmonization (ICH) guidelines and electronic common technical document (eCTD) formatting
• Strong understanding of CMC requirements for regulatory submissions with experience in CMC consulting, including IND authoring
• Willingness to train colleagues in CMC requirements and documentation
• Ability to prioritize tasks and delegate when appropriate
• Ability to function well in a high-paced environment
• Proficient with Microsoft Office Suite or related software and EndNote or similar citation software
• Experience with expedited approval applications preferred but training will be provided on the job

What we promise

• Comprehensive benefit program, including medical, vision and dental insurance, 401(k) matching and a tuition reimbursement program
• Opportunities to build a rewarding career
• An inclusive culture that stands for integrity, innovation and growth

About Pace

Pace Science and Technology company makes the world a safer, healthier place. We partner with clients to provide the service, science, and laboratory data needed to make critical decisions that benefit us all. Through a nationwide laboratory network, Pace advances the science of businesses, industries, consulting firms, government agencies, and others. More at PACELABS.com.

Pace Analytical Services is a division of Pace Science and Technology, providing local testing and analytical services backed by a large, national laboratory network.

Pace Life Sciences is a division of Pace Science and Technology, providing full-service CDMO/CRO capabilities and professional services for in-house labs through a nationwide network of service centers, manufacturing sites and FDA-registered laboratories.

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