Regulatory Strategy, Director (Bay Area, Boston)

TL;DR

Regulatory Strategy, Director (Bay Area, Boston): Develop and execute regulatory program strategies and lead US and ex-US regulatory teams for assigned biotech, medtech, and specialty pharma projects with an accent on FDA/EMA agency interactions and submission strategy. Focus on building IND and NDA/BLA/MAA submission plans, leading contingencies, and ensuring regulatory success across multiple development phases and therapeutic areas.

Location: San Francisco, CA (Preferred: San Francisco or Boston)

Salary: $150,000.00 USD minimum base pay annually

Company

hirify.global supports biotech, medtech, and specialty pharma companies in transforming breakthrough science into new medicines, devices, and diagnostics.

What you will do

• Develop and execute regulatory program strategies and contingencies for assigned projects.
• Lead US and ex-US regulatory teams on assigned projects.
• Design creative approaches to drive regulatory success.
• Serve as regulatory representation with clients and internally, including key interactions with the Food and Drug Administration (FDA) and other agencies.
• Act as primary point of contact for FDA/EMA/national agencies on assigned projects.
• Lead preparation of submissions, including INDs, briefing documents, orphan drug applications, breakthrough designations, and NDA/BLA/MAA (and related materials).

Requirements

• Bachelor’s degree (or international equivalent) in a science or health-related field; Master’s degree or PhD preferred.
• 12+ years of experience in the CRO, pharmaceutical, biotechnology, or device/diagnostics industry (advanced degree may substitute for part of industry experience).
• 8–9 years of progressive regulatory affairs experience (US and/or ex-US) for a CRO/biotech/pharma, including 4+ years as a consultant.
• Demonstrated experience interacting with FDA, European Medicines Agency (EMA), and other regulatory agencies.
• Demonstrated leadership experience in opening INDs and in submission and approvals of NDAs/B(L)As/MAAs.
• Expertise in drug development across multiple phases (early/late stage, post-approval) and product types (drugs, biologics, drug-drug combinations, drug-device combination products).

Culture & Benefits

• Support for growth with flexibility and work-life balance.
• Compensation aligned with market standards, including a comprehensive benefits package (health insurance, retirement plans, paid time off).
• Work focused on delivering medical innovation for patients.
• Equal opportunity employer with compliance to federal guidelines.