Strategic Director, Regulatory Affairs — Remote

Veristat, LLC; 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 is seeking a Director of Regulatory Affairs to drive regulatory strategy and client engagements for early development through NDA/BLA. You will independently prepare regulatory submissions like US IND, NDA/BLA modules, ODD, and designation requests, and lead interactions with FDA and Health Authorities.

Join a global team with 30+ years of CRO life sciences expertise, delivering numerous approvals and oncology/rare disease projects, while benefiting from a flexible, largely remote

Qualifications

• Bachelor’s degree in science; advanced degree preferred.
• 10 years CRO/pharma experience with at least 5 years leading regulatory projects.
• Thorough knowledge of ICH GCP and regulatory rules.
• Excellent written and oral communication; strong regulatory terminology.

Responsibilities

• Provide strategic regulatory advice to clients across early development to NDA/BLA.
• Independently prepare regulatory documents (US IND, NDA/BLA modules, ODD, designations).
• Interact with FDA and Health Authorities as client face and agency contact.
• Lead regulatory development projects and coordinate cross-functional teams.

Skills

Regulatory leadership

ICH GCP knowledge

Scientific writing

Cross-functional collaboration

Education

Bachelor’s degree in science

Advanced scientific degree (MS/PhD/PharmD)

Tools

MS Word

MS Excel

Job description

Veristat is seeking a Director of Regulatory Affairs to drive regulatory strategy and client engagements for early development through NDA/BLA. You will independently prepare regulatory submissions like US IND, NDA/BLA modules, ODD, and designation requests, and lead interactions with FDA and Health Authorities.

Join a global team with 30+ years of CRO life sciences expertise, delivering numerous approvals and oncology/rare disease projects, while benefiting from a flexible, largely remote