Director, Global Regulatory Affairs

Responsibilities

• Oversight and quality assurance of regulatory submissions and related documents.
• Lead or support the drafting and submission of documents to health authorities, including scientific advice requests.
• Initiate strategic regulatory discussions and lead documentation processes on complex programs as a Global Regulatory Lead.
• Identify regulatory requirements and develop comprehensive strategies throughout the product lifecycle.
• Evaluate the regulatory landscape and communicate insights regarding competitor products.
• Facilitate communication between regulatory issues and functional areas, relaying concerns to senior leadership.
• Manage regulatory strategy teams, including mentoring and performance evaluations.

Qualifications

• Bachelor's degree required; Master's degree preferred.
• 10+ years of regulatory affairs experience in Life Sciences.
• Substantial neurology or oncology regulatory experience in pharma/biotech is essential.
• Experience with major FDA submissions and managing health authority interactions.
• Prominent ability to translate regulatory strategies into operational goals and effectively manage resources.
• Strong project management skills with a history of leading multiple critical projects.
• Experience in a supervisory role within regulatory strategy teams is preferred.

Benefits

• Eligible to participate in the annual incentive plan.
• Eligibility for the Long Term Incentive Plan.
• Access to comprehensive employee benefit programs.
• Opportunity for professional development and continuing education.