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Location: Ridgewood, NJ
Salary: $130,000.00 USD Annually – $160,000.00 USD Annually
Description
Our client is currently seeking a Senior Manager, Regulatory Affairs. This is a permanent, direct hire role offering hybrid work schedule.
Responsibilities
• Develop and implement global regulatory strategies for investigational and marketed pharmaceutical products
• Manage US and ex-US submissions, ensuring timelines and compliance.
• Liaise with FDA and regional regulatory leads; oversee consultants and vendors
• Represent regulatory affairs on project teams and support R&D and clinical research activities.
• Provide regulatory strategic support and guidance
• Research regulatory precedence and competitive intelligence
• Propose risk mitigation strategies for submissions and approvals
• Manage regulatory CROs and interactions with health authorities
• Plan and execute submissions for INDs, NDAs, and supplements
• Communicate health authority correspondence to senior leadership
Requirements
• BS/BA in Life Sciences; advanced degree preferred
• 5+ years in product regulatory experience; 3+ years in drug strategy and submissions
• Knowledge of FDA regulations, ICH guidelines
• Experience in regulatory strategy for branded products, rare diseases, and accelerated approvals
• Strong communication, analytical, and leadership skills
• Regulatory Affairs Certified is a plus
For immediate consideration email JGood@Judge.com.
Contact: jgood@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
