Vice President, Regulatory Affairs

Role Overview

• Develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization.
• Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies.
• Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions.
• Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

Requirements

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered.
• 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments.
• Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval.
• Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues.
• Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management.
• Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities.
• Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners.
• High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options