Manager, Regulatory CMC - Remote Job Listing at Kelly Services in Winston Salem, NC (Job ID US3589167_BH9916059)

Description

Job Title: Manager, Regulatory CMC (Contractor)
Hourly Pay Rate: $62.50
Schedule: Monday–Friday, 9:00 AM–5:00 PM (Must work Eastern Time hours)
Location: Remote
 

Position Summary:

An advanced therapy biotech organization is seeking a Manager, Regulatory CMC (Contractor) to provide specialized support for Chemistry, Manufacturing, and Controls (CMC) compliance and documentation activities. This fully remote role is ideal for a regulatory professional who already has experience in the biopharmaceutical or cell/gene therapy space and can independently manage CMC-related compliance tasks without requiring onboarding or training.

This position focuses on regulatory compliance support—including change controls and deviations—while contributing to high-quality regulatory documentation for U.S. and global filings. The successful candidate will bring a technical CMC background in analytical methods, manufacturing, or process development, and be ready to step in and support a dynamic and fast-paced regulatory team.

Key Responsibilities: Regulatory Compliance & Documentation:

• Review and support the preparation of CMC sections for global submissions (INDs, CTAs, amendments).

• Independently manage compliance tasks including change controls, deviation assessments, and documentation updates.

• Compile and analyze technical data from QA, QC, and Manufacturing teams to support regulatory filings.

• Ensure that all documentation aligns with regulatory standards (FDA, EMA, ICH) and internal SOPs.

• Assist in preparing responses to health authority queries related to CMC topics.

Technical Expertise:

• Apply strong technical knowledge in analytical methods, manufacturing processes, and/or process development to support CMC strategy and risk assessment.

• Evaluate regulatory impact of technical changes and participate in the decision-making process regarding filings.

Cross-functional Collaboration:

• Collaborate with cross-functional partners including Manufacturing, Quality Assurance, Quality Control, Process Development, and Regulatory Affairs.

• Operate autonomously with minimal supervision while ensuring alignment with team objectives and timelines.

Qualifications:

• Bachelor's or Master's degree in a scientific or engineering discipline (e.g., chemistry, biology, biochemistry, pharmaceutical sciences).

• Minimum 3 years of experience in Regulatory Affairs or relevant technical experience (Manufacturing, QA/QC, Process Development) in the biopharma or cell/gene therapy industry.

• Proven ability to independently manage regulatory compliance tasks including change controls and deviations.

• Strong CMC technical background with knowledge of analytical method development, manufacturing, or process development.

• Experience with global regulatory filings and knowledge of FDA, EMA, and ICH guidance.

• Exceptional written and verbal communication skills and attention to detail.

• Proficient in Microsoft Office and document management systems.

• Must be able to work effectively remotely, adhering to Eastern Time business hours.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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