Regulatory Affairs Lead

Fully remote position. Must have the right to work in the location.

About the role

Support regulatory strategies and ensure compliance with U.S. health authority requirements. Guide product development, prepare for FDA meetings, and manage communications with regulatory agencies.

Responsibilities

• Provide guidance on regulatory pathways to speed up product development, such as accelerated approvals or priority reviews.
• Prepare cross-functional teams for major FDA meetings and lead these discussions.
• Manage and respond to FDA information requests and other health authority communications.

Requirements

• A degree in a scientific field.
• Proven working history in regulatory affairs, including leading FDA meetings and submitting major applications.
• Strong leadership and teamwork abilities, with excellent verbal and written communication skills.
• Knowledge of regulatory standards, including GMPs, GLPs, and GCPs, and the ability to interpret regulatory guidelines.
• Commitment to ethical practices and sound decision-making in risk assessment.

Pay

$180,000 to $200,000 per annum.