Sr Regulatory Submissions Coordinator

Asklepios BioPharmaceutical Inc. (AskBio) is a leading clinicalstage gene therapy company founded in 2001 based on the work of adenoassociated virus (AAV) gene therapy visionary and pioneer Jude Samulski PhD. Since that time our commitment to developing lifesaving medicines that can potentially cure genetic diseases has never wavered.

At AskBio weve 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 Parkinsons disease and congestive heart failure. Our gene therapy platform includes Pro10 an industryleading proprietary cell line manufacturing process and an extensive AAV capsid and promoter library.

We became a whollyowned 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 Germany and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples 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 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 whats right in every situation. Make clear commitments and follow through.

Job Summary

The Sr. Regulatory Submissions Coordinator will be responsible and accountable for both routine and nonroutine submission coordination activities. This includes but is not limited to provision of templates document formatting publishing and archiving while also proactively setting standards within the Regulatory Operations team. The Sr. Regulatory Submissions Coordinator will deliver regulatory project management support to Regulatory Affairs Representatives and their respective project teams ensuring the timely and effective completion of regulatory deliverables and submissions. Additionally this role will involve assisting regulatory strategy development submission tracking and preparing and delivering status presentations to Senior Management. The Sr. Regulatory Submissions Coordinator will also play a key role in the implementation training and maintenance of the Companys Regulatory Information and Electronic Document Management Systems.

This role will report directly to the Sr. Director of Regulatory Operations;

The location of this hybrid position is in Durham (RTP) North Carolina or Philadelphia PA but other remote options may be considered.

Responsibilities

• Act as the lead subject matter expert (SME) and leader for all submissions by providing tactical and operational oversight for the planning preparation formatting publishing validation and timely submission of all assigned submissions which include but not limited to INDs BLAs DMFs IMPDs CTAs MAAs.
• Collaborate with regulatory strategists partner organizations and regulatory agencies utilizing applicable software for publishing or liaising with vendors all in alignment with established project timelines.
• For assigned submissions collaborate with regulatory leaders to establish the submission scope goals tracking/status and deliverables. Subsequently plan and schedule submission timelines and milestones accordingly.
• Coordinate and manage submission timelines for regulatory deliverables ensuring that content review and proper assembly of regulatory documentation are complete accurate compliant and submitted on time to achieve business objectives.
• Maintain ongoing communication with project stakeholders to monitor project milestones and deliverables develop deadlines and prepare progress reports for effective communication with management and other stakeholders.
• Additionally support crossfunctional project teams in developing timelines processes and submission guidance to facilitate timely compliant and highquality submissions.
• Manage the archiving of regulatory submissions and correspondences in the Regulatory Information Management (RIM) system.
• Act as a strategic leader and expert in the development and implementation of process improvements for dossier management publishing and archiving within the submission framework. Ensure consistency completeness and compliance to Health Authority electronic submission standards for all regulatory submissions.
• Attend and participate as a subject matter expert in project team meetings as required to assist in compilation of submissions.
• Support the adherence and use of the companys RIM system by participating in information gathering and standard setting for efficient business processes.
• Possess extensive experience compiling and publishing eCTD and noneCTD investigational submissions such as but not limited to US INDs US IND amendments Canadian CTAs IMPDs and other international submissions.

Required Education and Experience

• A minimum of a Bachelors degree 8 years experience in a scientific technical project management or IT discipline is desired; or 12 years Role Relevant Work Experience

Preferred Experience and Skills

• Expertise in compilation formatting publishing and placement of data and documents in eCTD format
• Experience working with external publishing vendors desired.
• Expertise in understanding CTD/eCTD submission structure and 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 crossfunctional teams.
• Superior knowledge of Microsoft Office suite Adobe Acrobat Adobe PlugIns (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 excel at multitasking maintain strong attention to detail and remain result driven to consistently meet 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.
• Strong understanding of the internal and external interdependencies among submission activities that impact the schedule or quality of a submission to proactively manage these interdependencies ensuring that submission goals are met in a timely manner and uphold the highest standards of 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 jobrelated 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 ator sending us an email at .

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.