Sr. Regulatory Submissions Coordinator

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, Germany, 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.
  
  

Job Summary

The Sr. Regulatory Submissions Coordinator, will be responsible and accountable for both routine and non-routine 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 Company’s 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 cross-functional project teams in developing timelines, processes, and submission guidance to facilitate timely, compliant, and high-quality 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 company’s RIM system by participating in information gathering and standard setting for efficient business processes.
• Possess extensive experience compiling and publishing eCTD and non-eCTD investigational submissions such as but not limited to US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions.
  
  

Required Education And Experience

• A minimum of a Bachelor’s 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 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 excel at multi-tasking, 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 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.