Senior Director, Global Regulatory Lead, GI & Inflammation

Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

Requirements

• Bachelor’s Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
• 12+ years of pharmaceutical industry experience
• 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience
• Experience in reviewing, authoring, or managing components of regulatory submissions
• Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits