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. Position Overview The Associate Director, Regulatory Operations, will be accountable for managing the routine and non-routine submission activities which will include but is not limited to providing templates, formatting, publishing, archiving, and setting standards within the Regulatory Operations team. The Associate Director will provide regulatory project management support to Regulatory Affairs Representatives and their project teams ensuring timely and effective completion of regulatory deliverables and submissions. The Associate Director will also support the implementation, staff training and maintenance of the Company’s Regulatory Information and Electronic Document Management Systems. This role will report directly to the Sr. Director of Regulatory Operations and can be remote. Responsibilities Provide operational oversight for the planning, preparation, formatting, publishing, validation, and timely submission of assigned submissions (to e.g., INDs, BLAs, DMFs, IMPDs, CTAs, MAAs etc.) to regulatory agencies using applicable software or liaising with vendors in accordance with established project timelines. For assigned submissions, work with the regulatory representatives to define submission scope, goals, and deliverables, then plan and schedule submission timelines and milestones. Coordinate and oversee the submission timelines for regulatory deliverables ensuring content, review, assembly of regulatory documentation is completed and submitted on time to meet business goals. For assigned submissions directly liaise with project stakeholders on an ongoing basis to track project milestones and deliverables, develop and control deadlines and prepare progress reports to effectively communicate to Management and other stakeholders. Support cross-functional project teams with developing timelines, processes, and submission guidance to ensure timely, compliant, high-quality submissions. Oversee the archiving of regulatory submissions and correspondences. Play a major role in developing and implementing submission process improvements for dossier management, publishing, and archiving. Ensure consistency, completeness, and adherence to Health Authority electronic submission standards for all regulatory submissions. Attend project team meetings as needed to assist in compilation of submissions. Support the implementation of the company’s RIM by participating in information gathering and standard setting for efficient business processes. Required Education and Experience A minimum of a Bachelor’s degree in a scientific or technical discipline A minimum of 7 years of experience in regulatory operations within the pharmaceutical industry. Preferred Experience and Skills Experience in publishing and compilation of eCTD submissions for US and EU filings and experience publishing electronic submissions in other regions is desirable. Experience working with external publishing vendors desired. Expertise in CTD/eCTD structure and requirements and an excellent understanding of submission requirements for global submission types (e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.). Excellent verbal and written communication and presentation skills. A strong training skill is a plus. Very strong interpersonal skills and ability to build relationships with cross-functional teams. Superior knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (PDF Tools, Toolbox, etc), eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology and project management tools are desired. Experience with document management systems such as Veeva Submisison/Submission Archive desirable Strong knowledge of StartingPoint (or similar eCTD authoring) templates. Demonstrated project management, organizational and planning skills. Ability to multi-task, attention to details, and end-result driven with meeting deadlines. Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities. Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines. Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality. Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency. 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.