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CMC Regulatory Affairs Specialist – Hybrid

  • Permanent
  • Anywhere

Website Pace Analytical Services, LLC

Pace Analytical Services, LLC

Company : Pace Analytical Services, LLC

Country: United States

Location : Vienna, Virginia

Post: Wed, 01 Feb 2023 20:35:12 GMT

Expires: Wed, 01 Mar 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

OVERVIEW:

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.

RESPONSIBILITIES:

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)

QUALIFICATIONS:

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 (url removed).

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.

IND2

About SPS at Pace Analytical: Like Pace®, our customers are continually innovating and looking for quality candidates to support their important work. As a member of the Pace® Scientific Insourcing Solutions team, you will have the opportunity to work directly with industry leaders who have scientific needs both inside and outside of the laboratory. OFCCP Statement: Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.

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