Director, Regulatory Affairs

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AskBio Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

💰 $2.7M Grant - Asklepios BioPharmaceutical on 2020-09

Healthcare • Manufacturing • Consulting

AskBio Inc. is a clinical-stage gene therapy company focused on developing adeno-associated virus (AAV)–based treatments for rare and genetic diseases. A wholly owned, independently operated subsidiary of Bayer AG, AskBio advances programs from discovery through manufacturing and clinical development, leveraging proprietary AAV capsids, promoters, and manufacturing technologies (e. g. , Pro10™ and neDNA™). The company runs clinical trials (e. g. , the AB-1009 program for late-onset Pompe disease), collaborates with academic and industry partners, and emphasizes patient-driven research to address unmet medical needs.

📋 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 other regulatory communications • Lead or participate in internal governance meetings, cross-functional project discussions, and regulatory agency interactions • Communicate regulatory strategy, risks, options, and recommendations to stakeholders and senior leaders • Collaborate with Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other functions • Provide guidance on European requirements, procedures, agency engagement, 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 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 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 • Sound judgment, problem-solving capability, attention to detail, and accountability • Proficiency with Veeva RIM or similar systems and Microsoft Office • Mission-driven, patient-focused mindset • Advanced degree in a scientific, medical, pharmacy, or related discipline preferred • Experience with European regulatory strategy preferred • Experience with integrated global regulatory strategies preferred • Experience with AAV-based gene therapy, rare disease, biologics, or advanced therapeutic medicinal products preferred