Job Description
Vital Therapies is hiring! www.vitaltherapies.com We are an exciting life science company located in
the Carmel Mountain Ranch area of San Diego. Vital Therapies is a pioneer and recognized world leader
in the treatment of acute liver failure. We are expanding our Regulatory Affairs/Quality team and are
currently hiring Director of Global Regulatory Affairs and Quality Operations (GRAQ). Candidate
should desire a fast paced and challenging small company environment, where we have smart people
accomplishing amazing things.
Qualified candidates may submit resumes and salary history to careers@vitaltherapies.com. If you are
submitting a resume from outside of San Diego, kindly include in your cover letter your relocation plans
and timing to be able to report to work in our San Diego facility.
Job Overview and Responsibilities:
The Director of Regulatory Operations is responsible for defining, implementing, and maintaining VTI
GRAQ document life cycle plans, policies, systems, and procedures and providing regulatory oversight of
submission publishing and archival. This includes defining the document management strategy for GXP
documentation, developing implementation plans and maintenance of processes to support efficient
electronic (and paper) regulatory filings, and GRAQ archival activities as well as the management of
regulatory document publishing. In addition, the role includes regulatory project management
(deliverables and timelines) for a complex combination product global filing strategy.
Role requires participation on cross-functional project teams, coordinating and/or overseeing all aspects
of regulatory submissions, and maintaining up-to-date knowledge and expertise of relevant FDA and ICH
guidelines and regulations.











Provides leadership and direction project team(s) to ensure timely and quality creation and
lifecycle management of global submissions by developing appropriate processes, procedures and
structure.
Provides leadership in the definition, implementation and maintenance of GXP document
management system(s) to ensure efficient and compliant GRAQ operations are maintained.
Provides regulatory project leadership in the development of a global combination product
submission structure and execution of submission deliverables timelines.
Ensures Regulatory Operations is in compliance with global regulatory agency requirements, and
appropriately oversees the management of the EDMS, publishing and eCTD software.
Produce high quality electronic regulatory submissions (planning, resource allocation, processing,
final product quality assurance). Ensure that direct reports have appropriate skill sets and IT
support to produce guidance compliant electronic submissions and subsequent e archiving.
Establish, update, and provide training on electronic submission operations, formats, templates,
policies, standards and procedures.
Represents Regulatory Affairs as a Subject Matter Expert (SME) in the design and
implementation of any technology facilitating the creation, maintenance or lifecycle management
of submissions in accordance with global agency guidelines and regulations.
Oversees the quality of metadata that is applied to the documents in EDMS.
Evaluates and addresses filing needs of the Regulatory Affairs department.
Represent Regulatory Operations group in planning meetings and advise Regulatory Affairs staff
on standard timelines for completion of submissions.
Prepare and maintain submission tracking documents and monitor status of submission
component completion, develop appropriate metrics.
Job Description



Ensures Regulatory Operations is available to support product team and manage
insourcing/outsourcing activities.
Assesses vendors and negotiates contracts for outsourcing/insourcing activities.
Participate in corporate teams. Advise and interact with electronic systems development
initiatives in other functional areas as required.
Job requirements:
 BA/BS in chemistry, biology, engineering or related pharmaceutical field required; advanced
degree preferred.
 10+ years of regulatory operations experience;
 Recent experience in leading the identification and roll out of EDMS, document life cycle, or
regulatory publishing systems
Vital Therapies offers competitive salary and benefits. Please send your salary requirements and cv to
careers@vitaltherapies.com. We are an Equal Opportunity Employer.