Director - Regulatory Affairs

Job Summary

Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development, and commercialization of our products across the portfolio!

About the Role

The client's pipeline of innovative medicines is consistently growing within Cardiovascular, Renal & Metabolism (CVRM). To meet the increasing demand for regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists. With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

Responsibilities

• Provides strategic and operational regulatory leadership to the development, commercialization, and life cycle management of assigned products.
• Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead.
• Works across disciplines to craft and implement the clinical strategy and influence health authorities to improve outcomes.
• Plays a substantial role in transforming exciting science into valued new medicines for patients around the world.
• Strategically thinks and evaluates risks to regulatory activities.
• Works strategically within a complex, business-critical and high-profile development program.

Requirements

• 5 years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Proven track record of regulatory drug development including product approval/launch.
• Experience in leading Major Health Authority interactions.

Skills

• Ability to think strategically and critically and evaluate risks to regulatory activities.

Qualifications

• Advanced Degree in Life Science or related discipline (required).

Benefits

• Medical, Vision, and Dental Insurance Plans.
• 401k Retirement Fund.

About the Client

This client is a leading biopharmaceutical organization operating globally within the life sciences sector, with a strong focus on Cardiovascular, Renal, and Metabolism (CVRM) therapeutic areas. The company employs regulatory affairs strategists, drug development scientists, quality assurance specialists, and research and development professionals across strategic locations including Gaithersburg, MD and other major U.S. research hubs. With a consistently growing pipeline of both small and large molecules, this organization engages thousands of scientific and regulatory professionals and partners with health authorities worldwide to bring innovative medicines to patients around the globe.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.