Regulatory Affairs Advisor

About the role

For our client, we are seeking a Regulatory Affairs Advisor to join the team of a leader in the Pharmaceuticals & Biotech space. This role will serve as a key regulatory partner on cross-functional teams supporting complex diagnostic and therapeutic programs. You will help shape regulatory strategy, guide submission planning, and support interactions with regulators and customers to advance compliant product clearance pathways. The position also includes mentoring team members and delivering training that strengthens regulatory capability across the organization. Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Represent the regulatory function on cross-functional teams
• Conduct interactions with customers and regulatory authorities regarding submissions
• Build and execute regulatory strategies for FDA Pharma and IVDR programs
• Advocate for least burdensome product clearance approaches while adhering to regulations
• Coordinate and prepare regulatory submissions with minimal supervision
• Mentor regulatory associates and support their career advancement
• Deliver training on regulatory topics across internal teams

Qualifications

• Bachelor's degree in a life science field or equivalent; advanced degree preferred
• Regulatory Affairs Certification (RAC) preferred
• 8+ years of direct regulatory experience in medical devices, LDTs, or pharma
• Direct experience with FDA Pharma and IVDR submissions is highly preferred
• Experience in organ health or women's health diagnostics is ideal

Pay

$146,100 – $182,600 annually

Benefits

• Remote work flexibility within the USA
• Opportunities for professional development and career advancement
• Engagement in a collaborative and innovative team environment