Company
GlobalRegulatorySubmissionManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Global Regulatory Submission Manager. Skills: Regulatory Submission Management, Global Regulatory Submissions, eCTD, Regulatory Compliance. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies”
Industry & Context.
anticipating technical obstacles and developing solutions; Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs
What They're Looking For.
Must Have
3-5 years of Regulatory Affairs or Regulatory submission related experience, BS in Life Sciences or a relevant discipline with at least 5 years of professional work experience, Experience with global regulatory submission formats, including familiarity with submission publishing activities, Familiar with the drug development process, Effective interpersonal skills, written and oral communication and presentation skills, Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously, Familiar with global Health Authority regulations/guidance eg. , FDA regulations, ICH and EMA guidelines/directives, Works independently and with minimal supervision, Proficiency with computer programs/systems (MS office, etc. ) with demonstrated ability to learn new systems quickly
Nice to Have
Master's degree preferred
What You'll Do.
Ensures a controlled documentation system
and information services including electronic records retention processes in accordance with regulatory requirements
Ensures compliance to the requirements from regulatory agencies
Maintains the technical and non-technical documentation change system
Assures procedures are in place to classify and maintain records
Interprets and enforces all documentation formatting
and operating procedure requirements
Drives cross-functional teams focused on the planning
compilation and dispatch of worldwide regulatory submissions
anticipating technical obstacles and developing solutions
Manages multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format
Provides guidance to project teams related to worldwide HA submission structure/format/requirements
submission filing strategy
eCTD document lifecycle management and submission compilation workflows
Tracks timely delivery of submission components
coordinates submission publishing activities with publishing team and organizes internal review and approvals
Effectively troubleshoots technical/quality issues relating to compilation
validation and dispatch of global submission outputs
Assesses publishing resource and support needs and develops/implements solutions to create efficiencies
How You'll Work.
Team & Collaboration
Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions; Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows; Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives
Communication Scope
written and oral communication and presentation skills
Process & Methodology
Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously
Full Job Description
**Job Description Summary** -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. **Job Description** **Key Responsibilities** • Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions. Manages multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]. • Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows. • Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals. • Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives. • Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs. • Assesses publishing resource and support needs and dev
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