Akebia Therapeutics
Associate Director, Regulatory Operations
Akebia Therapeutics, Cambridge, Massachusetts, us, 02140
Associate Director, Regulatory Operations
Regulatory AffairsCambridge, MA
About Akebia:Nearly 37 million Americans are currently affected by Chronic Kidney Disease. At Akebia, we take that number very seriously and every day we come to work with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.This is life-changing work, and we are all in, are you?Role Overview:The individual in this role brings a wealth of knowledge of regulatory submission requirements, which they leverage to collaborate with Regulatory Affairs and cross-functional departments. Their work is focused on ensuring that regulatory documentation is filed accurately and on time, with proper archiving, publishing, and management of content in information systems. This person provides guidance to help the department meet its application filing objectives, proactively identifies potential issues that may impact submission timelines, and drives process efficiencies to enhance operational effectiveness. They engage publishing vendors to ensure seamless publishing support and offer oversight and guidance on the Veeva RIM suite, identifying best practices for effective implementation.Key Responsibilities:Manage all regulatory operations activities including but not limited to project submission management, Smartsheet or MS project creation and management.Work collaboratively with Regulatory Affairs and contributing cross-functional team members to create and maintain regulatory submission project plans, manage deliverable timelines and activities, and work with the Regulatory lead to ensure issues, risks, or impacts due to changes in strategy and/or timelines are assessed quickly throughout the submission process.Track regulatory department information such as commitments with health authorities, contact information, NDA/IND commitments, etc.Work with an internal partner to manage all submissions and review for OPDP (2253) and SPL submissions.Act as an expert resource for eCTD submissions to FDA to ensure that documents, datasets, and compiled submissions meet internal and health authority standards in terms of quality, accuracy, and compliance.Maintain expert knowledge of electronic submission and computerized system validation standards.Support the development and maintenance of operations resources to ensure that submission documents across functional areas meet internal and health authority standards.Identify new or revised regulatory policies, processes, and SOPs and initiate activities to support compliance and departmental objectives.Serve as a primary contact with publishing vendor and other CRO(s) to coordinate activities and processes between external parties and the internal regulatory team.Support vendor selection process, implementation, maintenance, and troubleshooting of all regulatory-related information systems and software.Ensure effective Governance, Support, and Change Management for the onboarding and maintenance of the RIMs.Build and leverage relationships with industry, vendor, and trade associations to influence future regulatory environment from a regulatory operation perspective.Basic Qualifications:Bachelor's degree.8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations.Knowledge and understanding of the drug development process.Preferred Qualifications:Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.Strong knowledge of FDA regulations, guidelines, and/or specifications.Detail-oriented and highly organized.Knowledge and experience with Veeva RIM or other EDMS.Experience in working with vendors in support of regulatory submissions.Highly proficient in Microsoft Office suite, Project Management tools (Smartsheet), Adobe Acrobat, eCTD validation and viewing tools.Ability to lead complex projects and timelines in a matrix team environment.Strong team player, capable of working collaboratively and independently, with outstanding interpersonal and communication skills.Excitement about the vision and mission of Akebia.Compensation:Targeted Base: $158,619 - $195,941**Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown.COVID-19 Vaccination:
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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Regulatory AffairsCambridge, MA
About Akebia:Nearly 37 million Americans are currently affected by Chronic Kidney Disease. At Akebia, we take that number very seriously and every day we come to work with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.This is life-changing work, and we are all in, are you?Role Overview:The individual in this role brings a wealth of knowledge of regulatory submission requirements, which they leverage to collaborate with Regulatory Affairs and cross-functional departments. Their work is focused on ensuring that regulatory documentation is filed accurately and on time, with proper archiving, publishing, and management of content in information systems. This person provides guidance to help the department meet its application filing objectives, proactively identifies potential issues that may impact submission timelines, and drives process efficiencies to enhance operational effectiveness. They engage publishing vendors to ensure seamless publishing support and offer oversight and guidance on the Veeva RIM suite, identifying best practices for effective implementation.Key Responsibilities:Manage all regulatory operations activities including but not limited to project submission management, Smartsheet or MS project creation and management.Work collaboratively with Regulatory Affairs and contributing cross-functional team members to create and maintain regulatory submission project plans, manage deliverable timelines and activities, and work with the Regulatory lead to ensure issues, risks, or impacts due to changes in strategy and/or timelines are assessed quickly throughout the submission process.Track regulatory department information such as commitments with health authorities, contact information, NDA/IND commitments, etc.Work with an internal partner to manage all submissions and review for OPDP (2253) and SPL submissions.Act as an expert resource for eCTD submissions to FDA to ensure that documents, datasets, and compiled submissions meet internal and health authority standards in terms of quality, accuracy, and compliance.Maintain expert knowledge of electronic submission and computerized system validation standards.Support the development and maintenance of operations resources to ensure that submission documents across functional areas meet internal and health authority standards.Identify new or revised regulatory policies, processes, and SOPs and initiate activities to support compliance and departmental objectives.Serve as a primary contact with publishing vendor and other CRO(s) to coordinate activities and processes between external parties and the internal regulatory team.Support vendor selection process, implementation, maintenance, and troubleshooting of all regulatory-related information systems and software.Ensure effective Governance, Support, and Change Management for the onboarding and maintenance of the RIMs.Build and leverage relationships with industry, vendor, and trade associations to influence future regulatory environment from a regulatory operation perspective.Basic Qualifications:Bachelor's degree.8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations.Knowledge and understanding of the drug development process.Preferred Qualifications:Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills.Strong knowledge of FDA regulations, guidelines, and/or specifications.Detail-oriented and highly organized.Knowledge and experience with Veeva RIM or other EDMS.Experience in working with vendors in support of regulatory submissions.Highly proficient in Microsoft Office suite, Project Management tools (Smartsheet), Adobe Acrobat, eCTD validation and viewing tools.Ability to lead complex projects and timelines in a matrix team environment.Strong team player, capable of working collaboratively and independently, with outstanding interpersonal and communication skills.Excitement about the vision and mission of Akebia.Compensation:Targeted Base: $158,619 - $195,941**Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown.COVID-19 Vaccination:
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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