Senior Regulatory Affairs Leader — Global Submissions

Veristat; Northern (KY); Hybrid; USD 125,000 - 160,000; Full time

Benefits offered by this job

Remote work

Flexible time off

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Senior Regulatory Affairs Manager to guide global regulatory strategy and submissions for healthcare products. You will lead cross-functional teams, advise on agency interactions, and coordinate proactive regulatory planning to expedite clinical trials and marketing approvals.

The ideal candidate has 6–8 years in regulatory affairs within CRO/pharma, with strong knowledge of ICH guidelines, CMC, and excellent communication.

Qualifications

• 6–8 years of regulatory affairs experience in a CRO/pharma setting
• Thorough knowledge of ICH guidelines and regulatory guidelines in relevant territories
• Experience with global regulatory submissions and agency interactions
• Excellent written and oral communication skills and ability to translate regulatory requirements into actionable plans
• Demonstrated ability to lead by example and foster client relationships

Responsibilities

• Lead and manage regulatory submissions and filings for healthcare products
• Provide regulatory strategy guidance and consultation to Veristat clients
• Coordinate cross-functional teams and project timelines
• Communicate with regulatory agencies and manage agency communications

Skills

Regulatory affairs

Client relationships

Regulatory strategy

Cross-functional leadership

Written communication

Education

Bachelor's degree

Advanced scientific degree (PhD or Master)

Tools

Microsoft Word

Microsoft Excel

Job description

Veristat is seeking a Senior Regulatory Affairs Manager to guide global regulatory strategy and submissions for healthcare products. You will lead cross-functional teams, advise on agency interactions, and coordinate proactive regulatory planning to expedite clinical trials and marketing approvals.

The ideal candidate has 6–8 years in regulatory affairs within CRO/pharma, with strong knowledge of ICH guidelines, CMC, and excellent communication.