Senior Global Regulatory Affairs Leader

Veristat; United States; Remote; USD 125,000 - 160,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat in the United States seeks a Senior Regulatory Affairs Manager to oversee regulatory and cross-functional projects, providing strategic and operational support to clients in regulatory decision making, submissions, and product maintenance.

You will work with project teams, manage agency communications, and translate regulatory requirements into practical applications to drive successful clinical trials and submissions.

Qualifications

• Bachelor’s degree in a related field required; advanced scientific degree preferred.
• 6–8 years of regulatory affairs experience in CRO/pharma with global submissions.
• Familiar with manufacturing, specifications, analytical testing, and regulatory CMC requirements.
• ICH guidelines and regulatory guidelines across relevant territories; drug development knowledge.

Responsibilities

• Manage regulatory and cross-functional projects; provide strategic and operational support to Veristat clients for regulatory decisions, filings, and maintenance of healthcare products.
• Advise on regulatory agency interactions; manage agency communications; support preparation of submissions; build rapport with clients.

Skills

Regulatory strategy

Leadership

Communication

Client relationships

Project management

Education

Bachelor’s degree in related field

Advanced scientific degree (PhD or Master’s)

Tools

Microsoft Word

Microsoft Excel

Job description

Veristat in the United States seeks a Senior Regulatory Affairs Manager to oversee regulatory and cross-functional projects, providing strategic and operational support to clients in regulatory decision making, submissions, and product maintenance.

You will work with project teams, manage agency communications, and translate regulatory requirements into practical applications to drive successful clinical trials and submissions.