CMC Regulatory Scientist (Pharmaceuticals)

Location: Rahway, New Jersey, United States

Salary: $144,900–$151,800 per year

Company

hirify.global provides staffing and professional workforce services, including regulatory and pharmaceutical assignments.

What you will do

• Develop CMC regulatory submission strategies and timelines for assigned pharmaceutical projects and products.
• Prepare and review regulatory CMC dossiers for new products and existing commercial products.
• Manage renewals, annual reports, variations, supplements, and responses to regulatory authority questions.
• Assess post-approval changes, define filing strategies and timelines, and propose risk mitigation plans.
• Participate in new product development teams and deliver assigned regulatory milestones.
• Maintain regulatory information, identify potential compliance issues, and communicate risks to management.

Requirements

• Experience with CMC regulatory submissions and dossier preparation for pharmaceutical products.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Knowledge of CMC regulations, regulatory guidance, authority expectations, and industry standards.
• Working knowledge of FDA-CVM, EMA, and VICH requirements.
• Role location: Rahway, New Jersey, United States.

Culture & Benefits

• Temporary assignments lasting 13 weeks or longer may include medical, dental, and vision coverage.
• 401(k) and statutory sick pay may be provided where required.
• Reasonable accommodations are available during the employment process.