Senior Manager, Regulatory Affairs

The Judge Group; Ridgewood (NJ); Hybrid; USD 100,000 - 130,000; Full time

Job summary

A leading company is seeking a Senior Manager in Regulatory Affairs to develop global strategies for pharmaceutical products. This permanent role offers a hybrid work schedule and involves managing submissions, liaising with the FDA, and providing strategic guidance.

Qualifications

• 5+ years in product regulatory experience.
• 3+ years in drug strategy and submissions.

Responsibilities

• Develop and implement global regulatory strategies.
• Manage US and ex-US submissions.
• Liaise with FDA and oversee consultants.

Skills

Communication

Analytical

Leadership

Education

BS / BA in Life Sciences

Advanced degree preferred

Job 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

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Senior Manager Regulatory • Ridgewood, NJ