Regulatory Submission Associate
SPECTRAFORCE, Des Plaines, IL, United States
Job Title: Regulatory Submission Associate
Duration: 08 Months
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.
This individual must be able to understand the submission process, its requirements, timelines and assist others to resolve issues that could negatively affect getting work completed.
The candidate will 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 escalates as appropriate to upper management. As an individual contributor, the function of the Submission Project Management Associate is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
The individual may execute tasks and exercise influence generally at the middle management level.
The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Regulatory Knowledge / Skills
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.
#J-18808-Ljbffr
Duration: 08 Months
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.
This individual must be able to understand the submission process, its requirements, timelines and assist others to resolve issues that could negatively affect getting work completed.
The candidate will 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 escalates as appropriate to upper management. As an individual contributor, the function of the Submission Project Management Associate is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
The individual may execute tasks and exercise influence generally at the middle management level.
The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Regulatory Knowledge / Skills
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.
#J-18808-Ljbffr