VP, Regulatory Affairs | REMOTE

Vice President, Regulatory Affairs | REMOTE | Pre-IPO

Critical Elements

• Directly oversaw, or significantly contributed to, 2+ successful NDAs
• Global regulatory approvals
• Significant post-approval experience
• Inspection readiness - labeling
• Small company background
• Nimble - Adadptable - Entreprenurial
• Support within aggressive risk parameters

Overview

Were looking for a regulatory leader whos done this beforesomeone whos successfully led multiple NDA submissions, can guide a team through inspection readiness with confidence, and thrives in the dynamic pace of a small biotech. Reporting directly to an Executive Officer, youll play a central role in advancing our late-stage programs globally. This isnt a set the strategy and delegate positionits a roll-up-your-sleeves, be-in-the-details, steer-the-ship kind of role.

What Youll Do

• Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation.
• Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
• Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization.
• Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
• Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
• Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
• Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
• Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
• Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action.

What You Bring

• PharmD, PhD, or MD strongly preferred.
• Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience.
• Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement.
• Proven track record preparing for and navigating regulatory inspectionscalm under pressure, thorough in execution.
• Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture.
• Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS.
• Comfortable leading Advisory Committee strategies and commercial label expansion efforts.
• Fluent in GxP, FDA/ICH guidance, and global PV standards.
• Experience with small molecule programs, ideally in immunology or autoimmune indications.
• Skilled at toggling between high-level strategy and detail-driven executionyou dont shy away from writing submissions yourself.
• Clear communicator, quick thinker, strong collaborator, and decisive leader.