Regulatory Affairs Director - Pharma & Biotech (Hybrid)

ClinChoice; United States; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

ClinChoice is seeking a Director of Regulatory Affairs for Pharmaceuticals and Biotech. This hybrid, permanent role leads regulatory strategy and execution for North America and collaborates with cross-functional teams to ensure timely submissions and global compliance.

The candidate will have extensive FDA experience, develop regulatory strategies for INDs/NDAs/MAAs, mentor teams, and drive process improvements within a fast-paced CRO environment.

Qualifications

• Eight or more years in Regulatory Affairs for biopharmaceutical products.
• Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs.
• Direct experience working with the FDA and health authorities.
• Strong knowledge of regulatory lifecycle across development, CMC, labeling, promotion, commercialization.

Responsibilities

• Provide strategic and tactical leadership of the regulatory affairs function in North America.
• Lead client interactions and act as SME on regulatory projects for biopharma clients.
• Ensure compliance with government regulations, guidelines, and best practices.
• Collaborate globally to devise and implement regulatory strategy for client projects.
• Oversee preparation of regulatory documents and submissions (INDs, CTAs, NDAs, MAAs, BLAs).
• Mentor internal team across regulatory projects.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional leadership

IND/CTA/NDAs

Education

Bachelor in Science

PharmD/PhD preferred

Job description

ClinChoice is seeking a Director of Regulatory Affairs for Pharmaceuticals and Biotech. This hybrid, permanent role leads regulatory strategy and execution for North America and collaborates with cross-functional teams to ensure timely submissions and global compliance.

The candidate will have extensive FDA experience, develop regulatory strategies for INDs/NDAs/MAAs, mentor teams, and drive process improvements within a fast-paced CRO environment.