Associate Director / Director, Regulatory Strategy

About This Role

This role will provide strategic and tactical leadership to Rho's clients and project teams, supporting interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions.

Responsibilities

• Serve as an integrated product development and regulatory expert, responsible for product development activities and services to support client development programs and regulatory submissions.
• Lead integrated pharmaceutical, biologic, and medical device product development programs.
• Provide leadership, guidance, and support to large scope teams, programs, or projects.
• Mentor and advise staff, providing strategic and tactical guidance, fostering team unity, and giving feedback.
• Proactively identify risks, critically analyze problems, and develop contingency plans.
• Facilitate achievement of strategic goals for a program.
• Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals.
• Ensure effective, accurate and timely communication of key issues and progress to stakeholders.
• Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions projects.
• Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents.
• Develop and review clinical study protocols, investigator's brochures, and clinical study reports.
• Lead the planning, preparation, and conduct of regulatory authority meetings.

Requirements

• 5-8 years in development programs with clinical, nonclinical, CMC and regulatory experience
• Experience with FDA
• Excellent written, verbal, and interpersonal communication skills
• Ability to understand and motivate others and build effective teams
• Excellent presentation and critical thinking skills
• Ability to handle multiple projects and priorities with exceptional organizational and time management skills
• Proficient in MS Project, Excel, PowerPoint, Word and experience working within shared work environments

Qualifications

• PhD/PharmD or equivalent demonstration of analytical ability
• 5-8 years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience

Nice to Have

• Experience with ex-US regulatory authorities (meetings, submissions, strategy)

Skills

* Required skills

Benefits

Certifications