Senior Regulatory Affairs Director - Remote + Flexible Time Off

Veristat; United States; Remote; 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 is seeking a Director, Regulatory Affairs to lead strategic and operational regulatory consulting for client companies. This client-facing role manages interactions with FDA and Health Authorities, guiding development from early programs to NDA/BLA submissions.

You will prepare regulatory documents, mentor cross-functional teams, and collaborate with business development and marketing. A strong CRO/pharma background, ICH-GCP knowledge, and exceptional scientific writing are essential.

Qualifications

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field.
• Advanced scientific degree (Master’s, Ph.D. or Pharm.D.) preferred, with trial-focused training.

Responsibilities

• Provide strategic regulatory advice to clients, from early development to NDA/BLA stages.
• Individually prepare regulatory documentation (IND, NDA/BLA modules, ODD, designations).
• Lead scientific interactions with internal cross-functional teams and agency stakeholders (FDA).
• Maintain client-facing relationships and support business development and marketing efforts.
• Mentor and guide regulatory staff on regulatory strategy and submissions.

Skills

Regulatory Strategy

Regulatory Submissions

Lead Cross-functional Teams

ICH GCP Knowledge

Clinical Trials Regulatory

Education

Bachelor’s degree in science/related field

Advanced degree (MSc/PhD/PharmD) preferred

Tools

MS Word

MS Excel

Job description

Veristat is seeking a Director, Regulatory Affairs to lead strategic and operational regulatory consulting for client companies. This client-facing role manages interactions with FDA and Health Authorities, guiding development from early programs to NDA/BLA submissions.

You will prepare regulatory documents, mentor cross-functional teams, and collaborate with business development and marketing. A strong CRO/pharma background, ICH-GCP knowledge, and exceptional scientific writing are essential.