Manager, Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the timely delivery of high-quality regulatory publishing outputs in alignment with designated programs/products.

• Assess the implications of updates in agency guidance that pertain to submission processes.

• Initiate innovative process improvements to enhance efficiency.

• Manage regulatory publishing and submission tasks, ensuring proper monitoring and oversight.

• Lead or assist with Global Regulatory Affairs (GRA) initiatives.

• Guarantee the quality, timeliness, and budget adherence of assigned submissions.

• Serve as the main point of contact for coordinating regulatory publishing efforts within R&D functions.

• Collaborate with affiliates to coordinate and publish specified content.

• Take ownership of electronic regulatory submissions, ensuring compliance with health authority regulations and timelines.

• Design and implement systems and processes to optimize electronic lifecycle and maintenance submissions.

• Oversee submission and archival tasks.

• Supervise staff and contingent workers conducting document quality-control checks to ensure adherence to electronic regulatory standards.

• Manage project team members and assign tasks to vendor partners.

• Lead and direct Process Mapping Teams.

• Create and maintain regulatory operations work instructions.

• Foster collaborative relationships with colleagues.

• Organize and maintain regulatory documentation.

• Provide guidance on regulatory publishing to other departments and functions.

⛳️ Requirements

• A minimum of 5 years of experience in regulatory operations.

• Extensive hands-on experience with electronic application submissions.

• Familiarity with FDA, EMA, Health Canada, and Swissmedic regulations and guidance for both electronic and paper submissions.

• Strong knowledge and experience in regulatory operations, including eCTD sequences for formatting, publishing, submitting, lifecycling, and archiving.

• Proven track record of managing and producing time-sensitive deliverables.

• Expertise in Document Management Systems, preferably Documentum.

• Experience with publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox.

• Strong computer proficiency, with demonstrated experience using the Microsoft Office suite (Word, Excel, Access, and PowerPoint) and SharePoint.

• Knowledge of developing technology-driven processes across various departments/divisions.

• Recent experience with NDAs/MAAs is crucial.

• Strong leadership and staff management abilities.

• Demonstrated capacity to resolve complex challenges through innovative problem-solving.

• Well-articulated written and verbal communication skills.

• Ability to work efficiently in a global, matrixed, multicultural, and collaborative environment.

• Capability to engage effectively in multiple initiatives concurrently.

• Preferred certification includes Regulatory Affairs Professionals Society (RAPS) certification.

• Prior project management experience is preferred.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Company-paid basic life insurance.

• Accidental death & dismemberment insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.