Regulatory Affairs Director
2 weeks ago
EPM Scientific is seeking a seasoned Director of Regulatory Affairs to drive our gene editing company's groundbreaking projects through the complex regulatory landscape with vision and precision.
This pivotal role will harness your strategic acumen and hands-on expertise to navigate regulatory requirements and lead critical registration efforts. As a proactive and results-driven leader, you'll thrive in a collaborative, diverse environment and shape effective regulatory pathways to advance our innovative therapies to market.
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.
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