Director of Global Regulatory Affairs - Confidential : Job Details

Director of Global Regulatory Affairs

About the Company

We are a leading provider of innovative pharmaceutical and biotechnology solutions.

Industry Pharmaceuticals

About the Role

Join our dynamic team as the Director of Global Regulatory Affairs, focusing on pivotal areas in neurology and oncology. In this impactful role, you will spearhead global regulatory strategies for product development and registration, overseeing the life-cycle management of our breakthrough therapies. Your leadership will guide regulatory teams to achieve their goals while ensuring adherence to compliance standards.

We are seeking a collaborative leader with a Bachelor's degree in a scientific discipline; a Master's or advanced degree is preferred. You should possess at least 12 years of pertinent industry experience, including a robust 10 years in regulatory affairs within the biotech or biopharmaceutical landscape.

Key responsibilities include:

• Serving as the lead regulatory representative on cross-functional project teams.
• Advising senior management on regulatory matters and maintaining proactive engagements with health authorities.
• Overseeing the preparation and submission of marketing applications in CTD format.
• Participating actively in health authority inspections and compliance audits.

The ideal candidate will possess a proven track record of successful interactions with global regulatory agencies, demonstrating strategic and operational expertise. Exceptional communication, interpersonal, and leadership skills are essential, alongside the ability to thrive in a matrix organization. A sense of urgency and a results-driven mindset are critical for success in this role.

Travel Percent Less than 10%

Functions

• Operations
• General Management
• Strategy