Senior Director, Regulatory Operations

📋 Description

• Lead global regulatory operations, overseeing electronic and paper submissions, publishing
• Develop, implement, and maintain submission strategies aligned with broader global regulatory
• Coordinate cross-functional submission planning, ensuring regulatory documents are delivered
• Establish and maintain compliant GxP electronic systems and paper-based processes that meet
• Lead the selection, implementation, validation, maintenance, and lifecycle management of regulatory
• Partner with Information Technology and other stakeholders to optimize regulatory systems and

🎯 Requirements

• Bachelor's degree in life sciences or related discipline with at least 12 years of regulatory
• At least 6 years of experience in a regulatory operations leadership role, including team
• Strong working knowledge of global regulatory submission requirements, including electronic Common
• Experience managing regulatory submission publishing tools, document templates, formatting
• Familiarity with Veeva Vault for Submissions or comparable regulatory information and document
• Knowledge of applicable U.S. and international regulations, guidelines, and health authority

🎁 Benefits

• Annual salary: Estimated range of $265,000–$295,000 USD, depending on qualifications, experience
• Performance incentives: Eligibility to participate in performance-based bonus programs.
• Equity opportunities: Access to stock-based compensation programs.
• Comprehensive benefits: A competitive benefits package designed to support employee well-being and
• Work flexibility: Remote opportunities available within continental United States, with Hayward or
• Leadership impact: The opportunity to influence global regulatory operations strategy, technology