Associate Director, EU Regulatory Strategy

About AskBio Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people’s lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need.  Provide an environment for employees to reach their fullest potential.  Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. We have an opportunity for a Associate Director, Regulatory Strategy (EU) to join the AskBio team and  be part of our continued success! Position Overview  The Associate Director, EU Regulatory Strategy, reporting to the Senior Director, EU Regulatory Affairs, will serve as the regulatory strategy EU lead for assigned projects and provide regulatory leadership and direction for pre-clinical, clinical regulatory strategies in EU territories for AskBio’s development gene therapy products, work as the Regulatory EU Lead closely with cross-functional Regulatory team and Global Project Team members and subject matter experts to ensure that the EU regulatory strategy is aligned with regulatory requirements and expectations and that regulatory documents are high quality and submitted in a timely manner. This position will also provide product regulatory strategy and direction to internal customers, lead/participate in agency engagement activities, and manage external CRO interactions. This is an EU-based position. Responsibilities Serve as regulatory EU lead/representative, provide regulatory guidance and interpretation to guide the product development efforts in good alignment with EU regulatory requirements and expectations. Formulate preclinical and clinical regulatory strategies for the