Hybrid Director, Regulatory Affairs - Pharmaceuticals

at Stryker

• Job title: Director, Regulatory Affairs - Pharmaceuticals
• Job type: Full Time
• Experience level: Lead
• Salary: $167,000 - $362,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.

Responsibilities

• Provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit’s drug product.
• Interacts with the business unit’s cross-functional leadership team to support the direction, strategy, and growth of the organization.
• Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
• Creates long term regulatory strategy for drug products.
• Manages a regulatory affairs team responsible for the division’s pharmaceutical products.
• Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
• Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
• Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.

Requirements

• Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
• Minimum 15 years of experience, including 10 years in an FDA regulated industry
• 5 years of managerial experience preferred
• Experience with successful NDA and DINAs.
• Prefer additional experience with IDEs/ 510(k)s and/or combination products.

Benefits

• salary plus bonus eligible
• generally eligible for short-term and long-term financial incentives