Strategic Regulatory Affairs Director - Client-Facing

Veristat; North Carolina; On-site; USD 195,000 - 223,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat seeks a Director of Regulatory Affairs to lead strategic regulatory consulting for client programs from early development through NDA/BLA. You will prepare pivotal documents, interact with FDA and health authorities, and guide cross-functional teams.

The role combines regulatory leadership with client-facing BD responsibilities in a global setting. Ideal candidates have a decade in CRO/pharma, five years leading regulatory projects, and strong proficiency in ICH-GCP, writing, and

Qualifications

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field.
• Advanced scientific degree (Master’s, Ph.D. or Pharm.D.) preferred with applied training relevant to clinical trials.
• 10 years of relevant CRO/pharma experience, including at least 5 years leading regulatory development projects.
• Thorough knowledge of ICH GCP guidelines and other regulatory rules and guidelines.
• Excellent written and oral communication, including technical writing skills.

Responsibilities

• Provide strategic regulatory consulting from early development through NDA/BLA.
• Independently prepare regulatory documents such as US IND, NDA/BLA modules, ODD, and Fast Track designations.
• Interact with clients, FDA, and health authorities as main contact.
• Lead cross-functional scientific interactions and contribute to internal BD and marketing.
• Support business development and regulatory strategy across client programs.

Skills

Regulatory leadership

Regulatory development

GxP/ICH-GCP knowledge

Communication skills

Team leadership

Microsoft Word/Excel

Education

Bachelor's degree in science or related field

Advanced scientific degree (MS/PhD/Pharm.D.)

Tools

Microsoft Word

Microsoft Excel

Job description

Veristat seeks a Director of Regulatory Affairs to lead strategic regulatory consulting for client programs from early development through NDA/BLA. You will prepare pivotal documents, interact with FDA and health authorities, and guide cross-functional teams.

The role combines regulatory leadership with client-facing BD responsibilities in a global setting. Ideal candidates have a decade in CRO/pharma, five years leading regulatory projects, and strong proficiency in ICH-GCP, writing, and