The Director of Submission Sciences leads the Global Delivery Management function to ensure timely and quality regulatory submissions globally while driving operational excellence and strategic leadership
Job Summary
The Director of Submission Sciences leads the Global Delivery Management function to ensure timely and quality regulatory submissions globally while driving operational excellence and strategic leadership.
Biogen offers a competitive compensation package including base salary, short and long-term incentives, and a comprehensive benefits program supporting employees' physical, financial, emotional, and social well-being.
Biogen fosters an inclusive culture that values diversity and empowers employees to contribute to life-changing medicines with opportunities for learning, growth, and impact.
Matching Summary
The Director of Submission Sciences leads the Global Delivery Management function to ensure timely and quality regulatory submissions globally while driving operational excellence and strategic leadership.
Salary
Base: $202,000.00-$278,000.00; Bonus/Equity: Short and long-term incentives including cash bonus and equity opportunities; Benefits: Medical, dental, vision, life insurance, wellness programs, paid time off, 401(k) match, stock purchase plan, tuition reimbursement
Skills & Requirements
Must-have
Global electronic submissions management
eCTD publishing software expertise
Regulatory Operations leadership
ICH, FDA, EMA guidelines expertise
Budget development and management
Cross-functional collaboration
Nice-to-have
Process improvement leadership
Mentoring and team development
Strategic resource allocation
Influence without authority
Regulatory technology innovation
Strong financial acumen
Key Requirements
Bachelor’s Degree in life sciences
10-15 years regulatory operations experience
10-15 years leadership in IND/CTA/BLA/MDA/MAA publishing