Position Summary

The Director, Regulatory Affairs will serve as a U.S.-based regulatory strategy lead for assigned development programs, with responsibility for driving global regulatory strategy and providing focused leadership for regulatory activities. This role will provide regulatory direction for preclinical and clinical development of AskBio’s product candidates, working closely with cross-functional Regulatory team members, Global Project Teams, subject matter experts, and external partners to ensure regulatory strategies are aligned with applicable health authority requirements and expectations.

This position will support and/or lead interactions with global health authorities, including EMA and other European and ROW agencies, and will contribute to high-quality, timely regulatory submissions, agency meeting packages, regulatory designations, and development-stage submissions.

The role will report into Regulatory Affairs and work remotely from within the United States.

Job Responsibilities

• Serve as Regulatory Affairs lead or representative for assigned programs, providing strategic regulatory guidance and interpretation to support product development in alignment with applicable regulatory requirements and health authority expectations

• Develop and execute innovative, integrated regulatory strategies and timelines for assigned programs, including strategies that support global development and European regulatory objectives

• Lead or support preparation and submission of regulatory documents for clinical development programs, including CTAs, amendments, scientific advice briefing packages, regulatory designations, and future marketing application activities, as applicable

• Lead regulatory document review, comment resolution, and approval processes to ensure documents are high quality, scientifically sound, submission-ready, and aligned with regulatory strategy

• Prepare and/or contribute to health authority meeting requests, briefing documents, responses to questions, and other communications with regulatory authorities.

• Lead or participate in internal governance meetings, cross-functional project team discussions, and regulatory agency interactions, effectively communicating regulatory strategy, risks, options, and recommendations

• Collaborate closely with Clinical, Nonclinical, CMC, Quality, Medical, Project Management, and other functions to ensure regulatory strategies are appropriately integrated into development plans and executed in a timely manner

• Provide regulatory guidance on European requirements, expectations, procedures, and opportunities, including agency engagement and expedited development mechanisms where appropriate

• Manage or provide oversight of external regulatory partners, consultants, CROs, and vendors supporting assigned regulatory activities

• Support regulatory due diligence for busness development or licensing opportunities, as needed.

• Ensure regulatory activities are conducted in compliance with applicable regulations, guidelines, internal procedures, and quality standards by staying up to date on contemporary guidance, regulations and applicable directives and laws

• Demonstrate strong collaboration, accountability, sound judgment, and a patient-focused mindset in a fast-paced matrix environment

Minimum 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 and/or leading regulatory submissions, health authority interactions, or regulatory strategy for clinical-stage development programs

• Experience with authoring and submitting PINDs, CTAs and INDs for biologics, gene therapy, cell therapy, or other advanced therapeutic technologies

• Demonstrated ability to write, review, and provide strategic input on regulatory documents, including briefing packages, designation requests, clinical trial applications, amendments, responses to health authority questions, and marketing application components

• Strong understanding of FDA, EMA, MHRA, and other health authority regulations, guidelines, procedures, and expectations

• Excellent written and verbal communication skills, including the ability to build clear regulatory rationales and communicate complex issues effectively to cross-functional stakeholders and senior leaders

• Strong interpersonal, collaboration, negotiation, and influencing skills, with the ability to work effectively in a matrixed, fast-paced environment

• Sound judgment, problem-solving capability, attention to detail, and a high degree of accountability

• Proficiency with VEEVA RIM or similar systems, Microsoft Office products and applications commonly used in Regulatory Affairs

• Mission-driven, patient-focused mindset with enthusiasm for contributing to development of gene therapy products for patients with serious diseases

Preferred Education, Experience and Skills

• Advanced degree (MS, PhD, PharmD, MD or equivalent) in a scientific, medical, pharmacy, or related discipline

• Experience with European regulatory strategy, including CTAs, scientific advice, PRIME, ILAP, MAA planning, or interactions with EMA, MHRA, national competent authorities, or other European regulatory bodies

• Experience developing and executing integrated global regulatory strategies for clinical-stage and registration-directed programs

• Experience with AAV-based gene therapy, rare disease, biologics, or advanced therapeutic medicinal products