Regulatory Operations Director
8 hours ago
Akebia Therapeutics is seeking an experienced Associate Director, Regulatory Operations to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing all regulatory operations activities, including project submission management, Smartsheet or MS project creation and management.
Key Responsibilities:- Manage all regulatory operations activities, including 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.
- 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.
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Regulatory Operations Director
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