Medical Regulatory Lead

What you'll do

• Define regulatory standards and oversee MLR processes, non-promotional communications, medical inquiries, and adverse event reporting workflows.
• Partner with Product, Engineering, Legal, and Compliance to embed medical guardrails and regulatory requirements in platform workflows.
• Support enterprise sales and deployments, advise pharma stakeholders, and develop reusable regulatory playbooks and materials.

What they ask for

• 7–15 years of experience in regulatory operations or regulatory affairs within pharma, biotech, or life sciences services organizations.
• Deep working knowledge of MLR review, non-promotional communication standards, medical information operations, adverse event reporting, and pharmacovigilance regulations.
• Strong understanding of FDA and EMA frameworks for patient engagement, medical communications, and digital health technologies.
• Experience translating regulatory and medical requirements into operational workflows, product requirements, or technology specifications.

Nice to have

• Experience with digital health platforms, AI in healthcare, or patient engagement technologies.
• MD, PharmD, PhD, or advanced scientific degree; MBA, MPH, or MS also valued.

Tools

FDA, EMA, HIPAA, GDPR

AI focus

Partner with Product and Engineering to architect AI agents for medical affairs workflows and establish regulatory oversight for AI-enabled patient and HCP engagement.