Director, Regulatory Affairs

🕒 August 7

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

📋 Description

• Serve as Regulatory Affairs lead or representative for assigned programs, providing strategic regulatory guidance and interpretation • Develop and execute integrated regulatory strategies and timelines supporting global development and European regulatory objectives • Lead or support preparation and submission of regulatory documents, including CTAs, amendments, scientific advice briefing packages, regulatory designations, and marketing application activities • Lead regulatory document review, comment resolution, and approval processes • Prepare or contribute to health authority meeting requests, briefing documents, responses, and regulatory communications • Lead or participate in governance meetings, cross-functional project discussions, and regulatory agency interactions • Collaborate with Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other functions • Provide guidance on European regulatory requirements, procedures, opportunities, and expedited development mechanisms • Manage or oversee external regulatory partners, consultants, CROs, and vendors • Support regulatory due diligence for business development or licensing opportunities • Ensure regulatory activities comply with applicable regulations, guidelines, internal procedures, and quality standards

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, medical, pharmacy, or related discipline • 10+ years of regulatory affairs or related drug development experience in the pharmaceutical, biotechnology, or related industry • Experience supporting or leading regulatory submissions, health authority interactions, or regulatory strategy for clinical-stage development programs • Experience authoring and submitting PINDs, CTAs, and INDs for biologics, gene therapy, cell therapy, or other advanced therapeutic technologies • Ability to write, review, and provide strategic input on regulatory documents • Strong understanding of FDA, EMA, MHRA, and other health authority regulations, guidelines, procedures, and expectations • Excellent written and verbal communication skills • Strong interpersonal, collaboration, negotiation, and influencing skills in a matrixed, fast-paced environment • Sound judgment, problem-solving capability, attention to detail, and accountability • Proficiency with VEEVA RIM or similar systems and Microsoft Office products • Mission-driven, patient-focused mindset • Preferred: advanced degree and experience with European regulatory strategy, integrated global regulatory strategies, AAV-based gene therapy, rare disease, biologics, or advanced therapeutic medicinal products