Associate Director, Global Regulatory Affairs

Responsibilities

• Lead drafting and compilation of routine and complex regulatory submissions
• Manage reports and track submissions, approvals, and documentation
• Serve as a Regional or Global Regulatory Lead for new medicinal products
• Interface with and lead meetings with regulatory authorities
• Develop and implement regulatory strategies for assigned markets
• Lead planning and execution of product life cycle management activities
• Partner with project teams to assess regulatory support needs

Qualifications

• Bachelor's or advanced degree in sciences or a related field
• 6+ years of experience in the regulatory or R&D area
• Experience mentoring team members on regulatory strategies
• Experience developing global regulatory strategies
• Proven experience leading large and complex regulatory projects
• Experience engaging with cross-functional stakeholders
• Demonstrated strong performance in previous roles

Benefits

• Participation in annual incentive and long-term incentive plans
• Eligibility for company employee benefit programs

Pay

• $165,000 – $216,500 annually

Schedule

• Remote - US based candidates only
• No visa sponsorship available