Director, Regulatory Strategy
The role I am supporting is with a pioneering gene editing company, driving innovation in gene therapy and beyond. They are seeking a dynamic Director of Regulatory Strategy to steer our groundbreaking projects through the complex regulatory landscape with vision and precision.
In this pivotal role, you’ll harness your strategic acumen and hands-on expertise to navigate regulatory requirements and lead critical registration efforts. This is an unparalleled opportunity for a proactive and results-driven leader who thrives in a collaborative, diverse environment. Your role will be central to advancing our innovative therapies to market, as you shape effective regulatory pathways and ensure seamless interactions with health authorities across the globe.
Key Responsibilities:
- Tackle complex scientific issues and align them with regulatory strategy to forge successful pathways.
- Lead the preparation and submission of high-quality regulatory dossiers and clinical trial applications, collaborating cross-functionally and demonstrating exceptional writing prowess.
- Serve as the primary liaison with global health authorities, ensuring transparent, proactive communication to achieve project milestones.
- Oversee compliance with international regulatory guidelines for gene therapy products, including authoring and reviewing critical documentation.
- Work closely with Nonclinical, Tech Ops, Quality, and Clinical teams to meet deadlines and secure timely approvals.
Qualifications:
- Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmaceutical industry, particularly with biologics and regulatory affairs.
- Experience with gene or cell-based therapeutics, RNA-based therapeutics, or orphan drug development is highly preferred.
- Proven track record with BLA or MAA submissions and extensive knowledge of global regulatory health authorities and submission types.
- Exceptional communication skills, strategic leadership, and a commitment to high-quality, detail-oriented work.
