Senior Regulatory Affairs Lead – Drug Development & IND/NDA

US Tech Solutions; Lake Forest (IL); On-site; USD 100,000 - 130,000; Full time

Job summary

A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires a minimum of 5 years of experience in drug development, including direct management of new drug approvals. Responsibilities include regulatory guidance, communication with health authorities, and strategic planning for submissions. Join a dynamic team aiming for mutual growth and innovation in pharmaceutical projects.

Qualifications

• Minimum of 5 years of experience in drug development and registration activities.
• Experience managing an approved new drug from inception to market.
• Capability to lead and motivate staff.

Responsibilities

• Serve as senior regulatory affairs member of project teams focused on drug products.
• Provide regulatory guidance on compliance and FDA requirements.
• Develop regulatory submission strategies aligned with product development.
• Liaise with FDA and health authorities for IND and NDA projects.

Skills

Regulatory oversight

Drug development

Compliance knowledge

Leadership

Strategic development

Job description

A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires a minimum of 5 years of experience in drug development, including direct management of new drug approvals. Responsibilities include regulatory guidance, communication with health authorities, and strategic planning for submissions. Join a dynamic team aiming for mutual growth and innovation in pharmaceutical projects.