VP, Regulatory Affairs

Hamlyn Williams; United States; Vor Ort; USD 150.000 - 250.000; Vollzeit

Zusammenfassung

An established industry player is seeking a VP/Head of Regulatory to spearhead their innovative gene therapy initiatives. This pivotal role involves shaping the regulatory strategy for AAV gene therapies, guiding them through preclinical development to clinical trials and regulatory approvals. You will collaborate with cross-functional teams to ensure compliance with FDA and EMA regulations while driving submissions and interactions with health authorities. This is a unique opportunity for a seasoned regulatory affairs expert to make a significant impact in a cutting-edge biotech environment, influencing the future of gene therapy and contributing to groundbreaking advancements in the field.

Qualifikationen

• 10+ years of regulatory affairs experience, with a focus on gene therapy.
• Proven track record of successful regulatory submissions for biologics.

Aufgaben

• Develop and execute global regulatory strategy for AAV-based gene therapies.
• Lead regulatory submissions and manage health authority interactions.

Kenntnisse

Regulatory Affairs

Gene Therapy

Leadership

Cross-functional Collaboration

Communication

Ausbildung

PhD in Life Sciences

PharmD

MS in Regulatory Affairs

Jobbeschreibung

I'm partnered with a Biotech company that is looking for a VP/Head of Regulatory to join their team. This role is critical in guiding their programs from preclinical development through clinical trials and regulatory approvals, ensuring compliance with FDA, EMA, and global regulatory frameworks. As a key leader, you will collaborate with R&D, clinical, quality, and commercial teams to drive regulatory submissions and interactions with health authorities. This is a high-impact leadership role for an expert in gene therapy regulatory affairs, offering the opportunity to shape the regulatory strategy of a cutting-edge AAV gene therapy pipeline.

Key Responsibilities

• Develop and execute global regulatory strategy for AAV-based gene therapies, ensuring compliance with FDA, EMA, and other regulatory bodies.
• Lead regulatory submissions, including IND, BLA, CTA, and MAA filings, and manage responses to health authority queries.
• Drive interactions with regulatory agencies, including strategy meetings (Pre-IND, Type B/C, Scientific Advice, Advisory Committees).
• Oversee CMC regulatory strategy, ensuring alignment with evolving gene therapy guidelines.
• Provide regulatory intelligence on emerging gene therapy regulations, guidance, and competitive landscapes.
• Partner with preclinical, clinical, and quality teams to ensure regulatory compliance throughout development.
• Develop and maintain risk mitigation strategies to address regulatory hurdles proactively.
• Represent regulatory affairs in board meetings, investor discussions, and external collaborations.

Basic Qualifications

• Advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, regulatory affairs, or a related field.
• 10+ years of regulatory affairs experience, with at least 5 years in gene therapy, AAV, or biologics.
• Proven track record of successful IND/CTA and BLA/MAA submissions for gene therapy or biologics.
• Strong understanding of FDA, EMA, and ICH guidelines for gene therapy and ATMPs.
• Experience in regulatory interactions, including FDA meetings and global regulatory agency negotiations.
• Expertise in CMC regulatory strategy for AAV or viral vector-based gene therapies.
• Strong leadership, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Prior experience leading regulatory strategy for first-in-class or orphan gene therapies.
• Knowledge of GMP requirements for AAV manufacturing and regulatory expectations.
• Experience with breakthrough designation, RMAT, and accelerated approval pathways.
• Familiarity with companion diagnostics and gene-editing regulations.

Seniority level

Executive

Employment type

Contract

Job function

Research and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing