Global Regulatory Submissions Lead (Hybrid/Remote)

Novartis Group Companies; United States; Hybrid; USD 91,000 - 169,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Car allowance

Job summary

Novartis is seeking a CTA/CTR Team Lead to lead a global regulatory team responsible for delivering high-quality regulatory submissions and approvals for clinical trials. You will combine leadership with regulatory expertise, driving improvements and partnering across the organization to enable an agile, future-ready Regulatory Affairs function.

The role emphasizes people development, strategic planning, cross-functional collaboration and Change leadership, with hybrid work options and

Qualifications

• Bachelor’s or Master’s degree in a science-related discipline with regulatory experience.
• Substantial knowledge of global regulations, guidelines and processes supporting regulatory clinical trial activities.
• Demonstrated experience leading regulatory professionals with people management and development capabilities.
• Strong experience in strategic planning, regulatory review, compliance, submissions and execution.
• Ability to drive process improvement, simplification, automation and operational excellence.
• Strong communication, influencing and problem-solving skills in cross-functional, international environments.

Responsibilities

• Lead and develop a global regulatory team delivering high-quality clinical trial submissions and approvals.
• Coach and develop team members, enabling growth.
• Allocate resources across the portfolio balancing priorities.
• Drive process improvement, simplification and automation for operational excellence.
• Build strong relationships with stakeholders and act on feedback.
• Foster collaboration across Regulatory Affairs and global teams.
• Champion Novartis culture, values and behaviours.

Skills

Regulatory leadership

People management

Regulatory submissions

Strategic planning

Cross-functional collaboration

Regulatory compliance

Communication & influencing

Education

Bachelor’s or Master’s degree in a science-related discipline

Job description

Novartis is seeking a CTA/CTR Team Lead to lead a global regulatory team responsible for delivering high-quality regulatory submissions and approvals for clinical trials. You will combine leadership with regulatory expertise, driving improvements and partnering across the organization to enable an agile, future-ready Regulatory Affairs function.

The role emphasizes people development, strategic planning, cross-functional collaboration and Change leadership, with hybrid work options and