As the Regulatory Manager, Clinical Trial Application Lead, you will coordinate and implement study startup activities in collaboration with CROs and internal teams to ensure timely and compliant clinical trial initiation
Job Summary
As the Regulatory Manager, Clinical Trial Application Lead, you will coordinate and implement study startup activities in collaboration with CROs and internal teams to ensure timely and compliant clinical trial initiation.
Biogen offers a competitive compensation package including base salary, cash bonus, equity incentives, and a comprehensive benefits program supporting employees’ physical, financial, emotional, and social well-being.
Biogen fosters an inclusive and diverse culture where individual contributions make a significant impact, providing opportunities for learning, growth, and delivering life-changing medicines.
Matching Summary
As the Regulatory Manager, Clinical Trial Application Lead, you will coordinate and implement study startup activities in collaboration with CROs and internal teams to ensure timely and compliant clinical trial initiation.
Salary
Base: $118,000.00-$158,000.00; Bonus/Equity: Cash bonus and equity incentives available; Benefits: Comprehensive medical, dental, vision, life insurance, wellness programs, paid time off, 401(k) with match, stock purchase plan, tuition reimbursement
Skills & Requirements
Must-have
Clinical trial application management
EU clinical trial regulation expertise
Collaboration with CROs and study teams
Regulatory submission preparation
Study startup coordination
Regulatory compliance monitoring
Nice-to-have
Strategic thinking and risk assessment
Effective communication and interpersonal skills
Project management proficiency
Documentation system expertise
Collaborative mindset
Process improvement orientation
Key Requirements
Bachelor’s degree in life sciences or related field
5+ years clinical trial startup and regulatory affairs experience
Experience with EU Clinical Trial Regulation (CTR)
Familiarity with global regulatory requirements
Ability to manage multiple priorities and deadlines