at Akebia Therapeutics in Chicago, Illinois, United States
Job Description
Associate Director, Regulatory Operations
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Regulatory Affairs
Remote
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ID:
24R-14
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Full-Time/Regular
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
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?
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.
The Associate Director, Regulatory Operations will:
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 works with the Regulatory lead to ensure issues, risks, or impact due to changes in strategy and/ or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.
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; resources include a style guide, document checklist, and Starting Point Templates
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 and to nurture cooperative and collaborative vendor relationships.
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. Participate in special projects and process improvement initiatives as needed.
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
Able to display excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory operation strategies.
Strong knowledge of FDA regulations, guidelines, and/or specifications (as it applies to Regulatory system activities especially CTD and eCTD structure).
Detail-oriented and highly organized.
Knowledge and experience with Veeva RIM or other EDMS
Experience in working with... For full info follow application link.
Akebia is an equal oppportunity 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.
