Regulatory Operations Project Manager

Our Fortune 500 client (One of the world's multinational pharmaceutical company) in Des Plains, IL is looking for hardworking, motivated talent to join their innovative team.

Location:

1350 East Touhy Avenue, Des Plains, IL – Fully Onsite.

Contract:

8‑month contract with possibility of extension.

Pay Range: $40‑45/hr.

• Regulatory Affairs background – Submissions, IVDR, etc.
• End‑to‑End Project Life Cycle

• The Submission Project Management Associate is a Regulatory Operations team member responsible for working with the product team members to create and deliver on the regulatory submission project plan deliverables and ensure that responsible parties are meeting expectations.
• Must be able to understand the submission process, its requirements, timelines and assist others to resolve issues that could negatively affect getting work completed.
• Provide transparency to project risks and issues to the team, develop/execute mitigation plans to eliminate those issues/risks for deliverables on the critical path and elevate as appropriate to upper management.
• Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
• Execute tasks and exercise influence generally at the middle management level.
• Assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

• Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Submission/registration types and requirements.
• Domestic and international regulatory guidelines, policies and regulations.
• Ethical guidelines of the regulatory profession, clinical research and regulatory process.

• Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non‑IT business applications and disciplines.
• Manage/direct all facets of single or multiple, multidimensional, mission‑critical projects through the Full Project Life Cycle.
• Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success.
• Deliver quality project solutions to business problems or issues within defined budgets and/or timelines.
• Provide expert project guidance/support proactively through project completion.
• Provide tracking, reporting, and presentation to management and users.