Remote Director of Regulatory Affairs — Strategy & FDA Liaison

Veristat; Canada; On-site; CAD 271,000 - 310,000; 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 oversee strategic and operational regulatory consulting for client companies. The role is client facing, leading regulatory documentation from IND through NDA/BLA, and coordinating with Health Authorities and FDA.

The Director will guide cross-functional teams, support business development, and represent regulatory expertise across trials, while contributing to an inclusive, global, and flexible work culture.

Qualifications

• Bachelor’s degree in science or related field required; advanced degree preferred.
• Experience in regulatory development projects and leading teams.
• Strong knowledge of ICH GCP guidelines and regulatory rules.

Responsibilities

• Provide strategic and operational regulatory consulting for client companies.
• Prepare regulatory documentation such as US IND, NDA/BLA modules, ODD, fast track or other designations.
• Lead interactions with Health Authorities and FDA.
• Mentor and collaborate with internal teams and BD/marketing.

Skills

Regulatory strategy

Client facing leadership

Regulatory writing

Cross-functional collaboration

Project management

Regulatory affairs expertise

Education

Bachelor’s degree in science, toxicology, pharmacology, engineering or related field

Advanced scientific degree (Master’s, Ph.D., Pharm.D.) preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Veristat is seeking a Director of Regulatory Affairs to oversee strategic and operational regulatory consulting for client companies. The role is client facing, leading regulatory documentation from IND through NDA/BLA, and coordinating with Health Authorities and FDA.

The Director will guide cross-functional teams, support business development, and represent regulatory expertise across trials, while contributing to an inclusive, global, and flexible work culture.