Red Nucleus

Compliance

• Provide legal document review support including non-disclosure agreements, statement of work and other legal documents and ensuring documents are fully executed and archived
• Managing and updating various planning and sales systems including contributing to invoices, timecards and various financial updates
• Assist with division communication and team calendar management including group meetings, trainings and conference coordination
• Collaborate with Marketing to develop and maintain RegOps marketing material, including outward facing social media engagements (i.e. LinkedIn) and proactively respond to prospective and potential future clients
• Contribute to formatting and quality checking of regulatory submission documents and reports as requested

Regulatory Operations Analyst

• Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.
• Project Management across all R&D contributors to global submissions
• Collaborate with R&D Operations Extended Leadership Team in overall management of RegOps team and Staff including managing direct reports, training and coaching junior staff.
• Acts as RegOps business development SME for clients or potential clients (e.g., contracts, negotiations, strategies).
• Analyze market trends, evaluate business models, and support clients in areas such as R&D strategy, commercialization, market access, and portfolio optimization.
• Manage regional submissions and support global submissions as a Lead Publisher.
• Proactively communicate requirements and issues to be considered to the Submission Team and contribute to achieving realistic timelines.
• Proactively collect necessary information from the Submission Team and plan all submission management related activities.
• Lead and support clients in global submissions and assessment and implementation of information, document, and labeling management technology.
• Proactively communicate with clients on submission requirements.
• Submission management lead for applications at various stages of drug development (pre-IND through marketed products) and across multiple regions (US, Canada, EU) as needed.
• Liaise with agency experts on electronic submission requirements.

Director – Regulatory Operations

• Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information
• Manage regional submissions and support global submissions
• Proactively communicates requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines
• Proactively collect necessary information from the Submission Team
• Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards
• Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools
• Analyze submissions and track and record life-cycle information in accordance with standards
• Perform complex searches on submission life-cycle information, as required
• Keep updated on regulatory authorities requirements on technical/format aspects of submissions worldwide and ensure their incorporation into RN standards
• Participate on special project teams (e.g., skill work, standards).

Associate Consultant, Regulatory Operations

Accountant

• Support month-end close and revenue recognition process
• Prepare revenue recognition reports
• Validate billing schedules against client Statements of Work
• Reconcile balance sheet accounts
• Coordinate with project managers to resolve discrepancies
• Perform monthly balance sheet analysis