Manager, Regulatory Affairs

Manager overseeing regulatory strategy and compliance for product portfolios across the lifecycle. Reports to senior leadership while coordinating with cross-functional teams and health authorities to ensure global regulatory alignment and successful market submissions.

Responsibilities

• Develop and execute regulatory strategies supporting business objectives for product lifecycle
• Lead regulatory activities for assigned portfolios, ensuring timely submissions and approvals
• Identify regulatory risks and implement mitigation strategies to support project success
• Serve as primary regulatory contact with health authorities for communications and interactions
• Lead and develop regulatory team members in collaborative, high-performing environment

Requirements

• Bachelor's degree in scientific discipline or equivalent
• 5+ years regulatory affairs or related regulated industry experience
• Project leadership and people management experience
• Knowledge of global regulatory requirements and submission processes
• Ability to assess regulatory risks and develop mitigation strategies
• Experience working with global health authorities and regulatory agencies
• Strong communication and stakeholder management skills

Compensation: $120,000-$165,000 base annually, plus $5,000 sign-on bonus