Senior Vice President, Regulatory Innovation and Policy (Pharma)

TL;DR

Senior Vice President, Regulatory Innovation and Policy (Pharma): Serve as lead regulatory strategist and scientific authority for client engagements across therapeutic areas including rare diseases, developing and executing strategies for IND, NDA, and BLA programs with an accent on FDA interactions and clinical development plans. Focus on preparing and leading high-stakes agency meetings, authoring key deliverables, and providing proactive regulatory intelligence.

Location: United States, remote supported with hybrid encouraged if within short commute of offices

Company

hirify.global provides end-to-end consulting solutions for biotech, med device, and pharmaceutical organizations across the product lifecycle, with expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.

What you will do

• Serve as lead regulatory strategist for client programs, developing strategies for IND, NDA, BLA submissions including biosimilars and gene therapies.
• Advise on clinical development plans, study designs, endpoints, and risk-benefit assessments aligned with FDA expectations.
• Prepare and lead FDA interactions such as Pre-IND, Type B/C, End-of-Phase, and pre-BLA/NDA meetings.
• Author, review, and approve major deliverables like briefing books, regulatory correspondence, and submission modules.
• Lead multidisciplinary teams, represent clients at FDA, EMA, and international meetings, and act as senior relationship lead for key accounts.
• Mentor consultants, lead internal training, contribute to business development, and support firm visibility through speaking and publications.

Requirements

• Deep expertise in regulatory sciences across therapeutic areas, including rare diseases, biosimilars, and gene therapies.
• Experience developing regulatory strategies for IND, NDA, BLA programs and leading FDA/EMA interactions.
• Strong scientific authority for clinical development plans, study designs, and risk-benefit assessments.
• Proven track record authoring high-stakes regulatory deliverables and representing clients in agency meetings.
• Ability to lead multidisciplinary teams, mentor staff, and contribute to business development.

Culture & Benefits

• Commitment to diversity, equity, and inclusion with a workplace encouraging authentic self-expression.
• Holistic approach as an Equal Opportunity Employer fostering innovation, collaboration, and entrepreneurial spirit.
• Remote working supported with hybrid encouraged near offices for in-person collaboration.
• All applications personally reviewed by recruitment team without AI screening, with response provided.