CMC Regulatory Scientist I

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. Familiarity with regulatory systems such as Veeva Vault and experience with dossier updates, CTD, renewals, variations/supplements, and responses to regulatory authority questions.

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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