Global Regulatory Strategy Director

Cristcot; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in the United States is seeking a Senior Director of Regulatory Affairs. This key leadership role involves managing global regulatory submissions and ensuring compliance across various products. The ideal candidate will have over 15 years of regulatory operations experience, with a strong focus on FDA regulations. Responsibilities include overseeing promotional materials, collaborating cross-functionally, and ensuring submission readiness. This position offers a unique opportunity to lead regulatory strategy and drive compliance initiatives in a dynamic environment.

Qualifications

• 15+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry.
• 5+ years specifically in FDA Advertising & Promotion.
• Proven track record in planning and managing global eCTD regulatory dossiers.

Responsibilities

• Lead global regulatory submission management for new drug applications.
• Ensure compliance with U.S. regulations and guidelines.
• Collaborate with multiple departments to align on regulatory timelines.

Skills

Regulatory Operations experience

FDA Advertising & Promotion

Strategic planning

Technical writing

Interdisciplinary teamwork

Education

Bachelor's degree in Life Sciences

PharmD, PhD, MS, JD, or MBA

Tools

eCTD publishing tools

Veeva Vault RIM

Lorenz docuBridge

Extedo

Job description

A leading pharmaceutical company in the United States is seeking a Senior Director of Regulatory Affairs. This key leadership role involves managing global regulatory submissions and ensuring compliance across various products. The ideal candidate will have over 15 years of regulatory operations experience, with a strong focus on FDA regulations. Responsibilities include overseeing promotional materials, collaborating cross-functionally, and ensuring submission readiness. This position offers a unique opportunity to lead regulatory strategy and drive compliance initiatives in a dynamic environment.