Senior CMC Regulatory Sciences Specialist Job Listing at Kelly Services in Bridgeton, MO (Job ID US3571917_BH9858482)

Description

Kelly Science has an Immediate opening for a Senior CMC Regulatory Sciences Specialist for our growing client near St. Louis, MO

Full-time

Direct Hire

Hybrid work schedule

Salary $90,000-$110,000

 

What You'll Do:

1. Regulatory Compliance & Submissions

• Prepare, review, and submit high-quality postapproval CMC regulatory submissions and related correspondence to the FDA/CVM.
• Collaborate with the CMC team to align on submission strategy and content.
• Maintain accurate records and ensure timely archiving of all regulatory documents.
• Participate in regulatory negotiations to support submission approvals.

Success looks like: Accurate and timely submissions that meet all CVM standards and support ongoing product availability.

2. Regulatory Strategy & Intelligence

• Monitor regulatory changes, industry trends, and FDA updates to inform compliance and postapproval strategies.
• Share regulatory intelligence and guidance with internal teams such as R&D, Quality, and Marketing.
• Participate in industry groups and cross-company initiatives to advocate for sound regulatory practices.

Success looks like: Well-informed, agile strategy that support product life cycle and market presence.

3. Cross-Functional Collaboration

• Engage with internal teams to troubleshoot product issues and coordinate timely documentation for CVM submissions.
• Support cost-saving initiatives and process improvements through regulatory insights.
• Provide support during FDA inspections and internal audits.

Success looks like: Smooth, proactive collaboration that ensures compliance and operational efficiency.

4. Regulatory Agency Relationships

• Cultivate productive, professional relationships with CVM and other regulatory authorities.
• Represent industry working groups and forums to shape the regulatory environment.

Success looks like: A positive reputation and strong standing with regulatory bodies.

What We're Looking For:

Education & Experience

• Bachelor's degree in Chemistry, Biology, Animal Science, or related field—or equivalent industry experience.
• 2–4 years of regulatory affairs experience, with at least 1 year in veterinary pharmaceuticals.
• Experience with FDA submissions, preferably CVM.
• Prior involvement in regulatory meetings or informal communications with the FDA is a plus.

Skills & Attributes

• Excellent technical writing and document management skills.
• Strong attention to detail and organizational capabilities.
• Proven ability to navigate complex regulations and produce results under tight timelines.
• Collaborative mindset with the ability to work across functions and influence outcomes.
• Skilled in Microsoft Office, Google Workspace, Adobe Acrobat; eSubmitter experience is a bonus.
• Ability to grasp and communicate scientific and regulatory concepts clearly.
• Comfort working in a dynamic, evolving regulatory environment.
• Willingness to travel up to 5% of the time.

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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