Global Regulatory Strategy Director

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 169,500 - 248,600; Full time

Benefits offered by this job

401(k) retirement plan

Pension

Medical, dental, and vision insurance

Flexible spending accounts

Life insurance

Employee assistance program

Job summary

Initial Therapeutics, Inc. seeks a Global Regulatory Lead in Indianapolis, IN. The role involves developing regulatory strategies, overseeing FDA interactions, and leading a cross-functional team. Candidates must possess an advanced scientific degree and substantial experience in regulatory affairs or drug development.

This position demands strong leadership and communication skills, with a focus on navigating complex regulatory environments. A competitive compensation package and relocation assistance will be provided.

Qualifications

• 8+ years of experience in regulatory affairs and/or drug development with an advanced degree.
• 10+ years of experience in regulatory affairs and/or drug development with a bachelor's or master's degree.
• Knowledge of global regulatory procedures and drug development processes.

Responsibilities

• Develop and execute global regulatory strategies.
• Oversee US FDA submissions and interactions.
• Lead a cross-functional Global Regulatory Team.
• Shape the external regulatory environment.

Skills

Regulatory affairs experience

Clinical regulatory sciences

Leadership

Communication skills

Education

Advanced scientific degree (PharmD, PhD)

Bachelor’s or Master's degree

Job description

Initial Therapeutics, Inc. seeks a Global Regulatory Lead in Indianapolis, IN. The role involves developing regulatory strategies, overseeing FDA interactions, and leading a cross-functional team. Candidates must possess an advanced scientific degree and substantial experience in regulatory affairs or drug development.

This position demands strong leadership and communication skills, with a focus on navigating complex regulatory environments. A competitive compensation package and relocation assistance will be provided.