Senior Manager, Regulatory Operations
Apply NowCompany: Xeris Pharmaceuticals
Location: Four States, WV 26572
Description:
Overview
The Senior Manager, Regulatory Publishing provides business critical insights using analytics, ensures cross functional alignment of goals, and helps teams execute corporate objectives. This position provides oversight for regulatory publishing activities and dispatch of compliant regulatory submission to health authorities in support of Xeris' product portfolio.
Responsibilities
Manage and coordinate publishing and submission of INDs, CTAs, NDAs, 2253s and safety reports in coordination with Regulatory Leads.
Track timely delivery of submission components, coordinate submission publishing activities with publishing team, and organize internal review and approvals.
Effectively troubleshoot technical/quality issues relating to compilation, validation, and dispatch of global submission outputs.
Upload and maintain drug listings on FDA's website for all appropriate applications.
Manage creation, revision and submission of labeling content compliant with SPL standards.
Original and lifecycle management of regulatory submissions in eCTD format.
Provide deep expertise on current regulatory publishing standards and requirements.
Works in conjunction with product development team members to develop processes for the creation of electronic submission-ready documents.
Provide technical review of critical components for accuracy, compliance with Health Authority requirements, and internal standards
Provide final Quality Control review of all published dossiers prior to submission to health authorities.
Maintain Veeva RIM archive of regulatory submissions and submission acknowledgment documentation
Maintain templates and style guides.
Assess publishing resource and support needs and develop/implement solutions to create efficiencies
Manage conflicts and escalate critical issues to the project sponsor.
Create and implement a communications plan to keep team members, stakeholders, and sponsors up to date on project status and issues.
Flexibly contribute to other project roles, as necessary
Qualifications
Bachelor's degree, preferably in a scientific field such as biochemistry or biology; relevant experience may be substituted.
Minimum 5 years of regulatory publishing experience in the pharmaceutical industry.
Strong knowledge of best industry practices for eCTD publishing and eCTD viewer. Demonstrated stakeholder management capability and ability to effectively collaborate across the organization; interact within and across the matrix to manage deliverables.
Understanding of operational and regulatory aspects of biopharma industry.
Sophisticated competency with Veeva systems, Global Submit, and Rosetta Phoenix.
Advanced MS Word and Adobe PDF knowledge required.
Competencies: Problem Solving, Critical Thinking, Confidentiality, Verbal & Written Communication skills, Presentation skills, Teamwork & Collaboration, Self-Starter
Working Conditions
Position may require periodic evening and weekend work, as necessary to fulfill obligations.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The Senior Manager, Regulatory Publishing provides business critical insights using analytics, ensures cross functional alignment of goals, and helps teams execute corporate objectives. This position provides oversight for regulatory publishing activities and dispatch of compliant regulatory submission to health authorities in support of Xeris' product portfolio.
Responsibilities
Manage and coordinate publishing and submission of INDs, CTAs, NDAs, 2253s and safety reports in coordination with Regulatory Leads.
Track timely delivery of submission components, coordinate submission publishing activities with publishing team, and organize internal review and approvals.
Effectively troubleshoot technical/quality issues relating to compilation, validation, and dispatch of global submission outputs.
Upload and maintain drug listings on FDA's website for all appropriate applications.
Manage creation, revision and submission of labeling content compliant with SPL standards.
Original and lifecycle management of regulatory submissions in eCTD format.
Provide deep expertise on current regulatory publishing standards and requirements.
Works in conjunction with product development team members to develop processes for the creation of electronic submission-ready documents.
Provide technical review of critical components for accuracy, compliance with Health Authority requirements, and internal standards
Provide final Quality Control review of all published dossiers prior to submission to health authorities.
Maintain Veeva RIM archive of regulatory submissions and submission acknowledgment documentation
Maintain templates and style guides.
Assess publishing resource and support needs and develop/implement solutions to create efficiencies
Manage conflicts and escalate critical issues to the project sponsor.
Create and implement a communications plan to keep team members, stakeholders, and sponsors up to date on project status and issues.
Flexibly contribute to other project roles, as necessary
Qualifications
Bachelor's degree, preferably in a scientific field such as biochemistry or biology; relevant experience may be substituted.
Minimum 5 years of regulatory publishing experience in the pharmaceutical industry.
Strong knowledge of best industry practices for eCTD publishing and eCTD viewer. Demonstrated stakeholder management capability and ability to effectively collaborate across the organization; interact within and across the matrix to manage deliverables.
Understanding of operational and regulatory aspects of biopharma industry.
Sophisticated competency with Veeva systems, Global Submit, and Rosetta Phoenix.
Advanced MS Word and Adobe PDF knowledge required.
Competencies: Problem Solving, Critical Thinking, Confidentiality, Verbal & Written Communication skills, Presentation skills, Teamwork & Collaboration, Self-Starter
Working Conditions
Position may require periodic evening and weekend work, as necessary to fulfill obligations.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.