Uniquity Design Group
Director, Regulatory Affairs Operations
Uniquity Design Group, Phila, Pennsylvania, United States
Location: Malvern, PA (Hybrid — on site in Malvern at least 2-3 days per month)
Reports to: Vice President, Regulatory Affairs
Job Description:
The successful candidate will lead Regulatory Operations for global submissions and lifecycle management. The individual will own submission planning and publishing, drive compliant document workflows, and steward the tools and vendors that make timely, high-quality filings possible. This is an individual contributorrole with significant matrix leadership and vendor oversight (no direct reports at this time). Responsibilities: Own global submissions across development and post-approval (e.g., IND/CTA, IMPD, NDA/BLA/MAA, and variations), ensuring on-time, right-first-time delivery. Plan and publish eCTD sequences; coordinate content plans, timelines, QC, and health authority gateway activities in collaboration with cross-functional authors. Run document workflows in the EDMS/RIM: train users, manage templates, and uphold naming/metadata standards for inspection-ready files. Oversee vendors for publishing/production: define SLAs, track quality and budgets, and resolve issues/escalations. Own processes & controls: maintain SOPs/WIs, apply regulatory intelligence, and lead CAPAs/continuous improvements. Evaluate and implement technology (e.g., EDMS/RIM, publishing tools), including upgrades, validation compliance, and best-practice adoption for current and emerging eCTD standards. What you'll bring: 10+ years in Regulatory Operations within biotech/pharma with hands-on ownership of global eCTD submissions and lifecycle management. Deep knowledge of ICH, regional requirements, and eCTD publishing standards; strong EDMS/RIM and document control expertise. Proficiency with publishing tools, Microsoft 365, and Adobe Acrobat; meticulous attention to formatting, hyperlinks, bookmarks, and QC. Demonstrated matrix leadership —influencing authors and reviewers without direct authority—andvendor managementexperience. Excellent project management , organization, and communication skills; thrives in a fast-paced, collaborative environment. Bachelor’s degree required, advanced degree a plus.
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The successful candidate will lead Regulatory Operations for global submissions and lifecycle management. The individual will own submission planning and publishing, drive compliant document workflows, and steward the tools and vendors that make timely, high-quality filings possible. This is an individual contributorrole with significant matrix leadership and vendor oversight (no direct reports at this time). Responsibilities: Own global submissions across development and post-approval (e.g., IND/CTA, IMPD, NDA/BLA/MAA, and variations), ensuring on-time, right-first-time delivery. Plan and publish eCTD sequences; coordinate content plans, timelines, QC, and health authority gateway activities in collaboration with cross-functional authors. Run document workflows in the EDMS/RIM: train users, manage templates, and uphold naming/metadata standards for inspection-ready files. Oversee vendors for publishing/production: define SLAs, track quality and budgets, and resolve issues/escalations. Own processes & controls: maintain SOPs/WIs, apply regulatory intelligence, and lead CAPAs/continuous improvements. Evaluate and implement technology (e.g., EDMS/RIM, publishing tools), including upgrades, validation compliance, and best-practice adoption for current and emerging eCTD standards. What you'll bring: 10+ years in Regulatory Operations within biotech/pharma with hands-on ownership of global eCTD submissions and lifecycle management. Deep knowledge of ICH, regional requirements, and eCTD publishing standards; strong EDMS/RIM and document control expertise. Proficiency with publishing tools, Microsoft 365, and Adobe Acrobat; meticulous attention to formatting, hyperlinks, bookmarks, and QC. Demonstrated matrix leadership —influencing authors and reviewers without direct authority—andvendor managementexperience. Excellent project management , organization, and communication skills; thrives in a fast-paced, collaborative environment. Bachelor’s degree required, advanced degree a plus.
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