Head of Regulatory Operations and Submission Management

uniQure•Lexington, KY

6d•$275,000 - $332,000

About The Position

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. The Head of Regulatory Operations and Submission Management will report to the Senior Vice President Global Regulatory Affairs. This role will be responsible for providing strategic and operational leadership for global regulatory operations and systems, submission management and execution across the product portfolio and lifecycle. This role is accountable to lead a high‑performing Regulatory Operations function and for ensuring submission quality, compliance with current regulations, and timeliness across global regions.

Requirements

Bachelor’s degree required.
15+ years of progressive experience in Regulatory Operations and global submission management/publishing within pharmaceutical and/or biotechnology organizations, including leadership responsibility.
Demonstrated experience leading end‑to‑end submission execution (planning, publishing, QC, dispatch, archival) for U.S. and ex‑U.S. submissions, with strong knowledge of global submission formats and technical standards (eCTD/CTD/ACTD, as applicable).
Proven experience serving as business owner and implementing/optimizing regulatory systems (e.g., RIM/publishing/content management), including data governance and user adoption.
Experience establishing SOPs/standards and driving operational and quality process improvements in a regulated environment.
Experience managing vendors/outsourcing partners and developing scalable operating models (insourcing/outsourcing mix) across different stages of company growth.
In-depth, working, knowledge and understanding of FDA, EMA and ICH regulations and guidelines governing electronic submission standards.
Expert knowledge of electronic submission publishing concepts and technical QC expectations (e.g., document formatting standards, hyperlinking/bookmarking, PDF technical requirements, metadata integrity).
Strong ability to lead and influence cross‑functional, matrixed teams, excellent stakeholder management and strong executive communication skills.
Comfortable with a player/coach role with an enterprise mindset

Responsibilities

Establish and lead the Regulatory Operations strategy and execution to deliver compliant, high‑quality global submissions and maintain submission/registration archives across the product lifecycle (development through post‑approval).
Build, develop, and manage a Regulatory Operations organization (direct reports, vendors and/or matrix resources), including capability building, training and performance management.
Oversee submission planning, tracking, publishing, compilation, QC, dispatch, and archiving for major submission types (e.g., INDs/CTAs, NDAs/BLAs/MAAs, amendments/supplements/variations, annual reports, and other lifecycle submissions), ensuring adherence to global health authority technical requirements and timelines.
Serve as the operational submission execution partner to Regulatory Strategy and Regulatory CMC leads and cross‑functional subject matter experts, translating regulatory milestones into feasible operational plans, resourcing models, and publishing schedules while proactively identifying risks and mitigation strategies.
Establish and lead Regulatory Operations process excellence, including creating/maintaining SOPs, work instructions, templates, style guides, and best practices for document readiness, publishing, archival, and controlled submission records.
Establish and manage quality systems for Regulatory Operations, including technical QC standards (formatting, hyperlinks/bookmarks, PDF requirements, metadata), submission readiness checks, error prevention, corrective actions, and continuous improvement initiatives.
Lead Regulatory Information Management (RIM) and publishing systems governance, acting as business owner for tools supporting submission planning/content management/publishing/archival and regulatory data integrity; partner with IT and Quality on validation, access controls, audit trails, change control, and vendor-managed services where applicable.
Oversee and manage external vendors/outsourcing partners (publishing, system providers, ancillary submission services) including scope definition, budgets, performance monitoring, and issue resolution.
Ensure inspection readiness for Regulatory Operations processes, regulated systems, and submission archives; support audits/inspections by preparing evidence packages, demonstrating system/process controls, and coordinating responses and CAPAs in partnership with Quality.
Maintain regulatory operations intelligence regarding evolving global electronic submission standards and operational requirements (e.g., agency technical specifications, lifecycle management expectations), and lead change implementation to keep the organization compliant and current.
Partner cross-functionally with Regulatory Affairs Strategy, Medical Writing, CMC/Technical Operations, Quality, Biometrics, Clinical Operations, IT and Project Management to embed operational excellence and predictable submission execution into integrated development plans.