CMC Regulatory Scientist I

JSG is recruiting a CMC Regulatory Scientist I for our client in Rahway NJ

We are seeking a highly motivated CMC Regulatory Scientist I to join our dynamic team. In this pivotal role, you will play a key part in developing regulatory strategies and ensuring compliance for innovative pharmaceutical products



Pay $73.30/hour



What You’ll Bring to the Table:

- Solid foundation in CMC and Regulatory Affairs with at least 2 years of relevant experience in pharmaceutical research, manufacturing, or quality.
- Proven ability to review scientific information and craft regulatory submissions in compliance with global standards.
- Familiarity with regulatory systems such as Veeva Vault and experience with dossier updates, CTD, renewals, variations/supplements, and responses to regulatory authority questions.
- Knowledge of key regulatory guidelines including FDA-CVM, EMA, and VICH, along with an understanding of EU/US regulatory expectations.
- Strong communication skills—both written and verbal—and the ability to collaborate effectively across cross-functional teams.


Nice to Have Skills:

- Previous CMC experience specifically in the pharmaceutical industry.
- Experience with quality, analytical, R&D method validation, or validation package preparation.
- Familiarity with global regulatory submission strategies and post-approval change assessments.


Preferred Education & Experience:

- Bachelor of Science degree in science, engineering, or a related field (advanced degrees are a plus).
- At least 2 years of hands-on experience in pharmaceutical development, manufacturing, or quality assurance.


Additional Requirements:

- Location: Rahway, NJ, with a hybrid work model (3 days onsite, 2 days WFH).




Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.



Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.



JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer.



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Skills:

Analysis Skills, Biotech and Pharmaceutical, Clinical Research, Communication Skills, Consulting, Cross-Functional, Drug Development, Drug Manufacturing, FDA Requirements, Maintain Compliance, Presentation/Verbal Skills, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Submissions, Research & Development (R&D), Strategic Planning, Team Player, Work From Home, Writing Skills



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Johnson Service Group




At JSG, We Understand People





It is our mission to empower people, help our clients reach their goals, and hire motivated individuals.

Since our start in 1984, we’ve worked hard to establish our present position as the most effective cross-industry staffing and consulting solution available.

Headquartered in Chicago, IL with local offices throughout the United States and Canada, JSG proudly serves a diverse range of industries with the right solutions to help clients reach their company goals. Our client-centric approach enables us to create personalized solutions for businesses in need of top-tier talent. Our dedication doesn’t stop at our clients. We strive to connect candidates with opportunities that match their skills and goals. More than just a go-between, we are a dependable bridge, uniting top talent with suitable opportunities, facilitating shared opportunities and growth.









Company Size:

1,000 to 1,499 employees



Industry:

Staffing/Employment Agencies



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Website:

https://www.jsginc.com/