Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?
If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.
As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following
Fulfil standard, ad hoc, or complex data reporting request and design outputs.
Assist Regulatory Business Operations (RBO) staff in delivery of projects.
Assist RBO staff in process documentation, monitoring, and reporting.
Maintain Team sites.
Adhere to records retention.
Complete appropriate training.
Assist Regulatory Business Operations staff to optimize project plan robustness (scope, deliverables, resources, timing).
Provide project support to meet assigned business deliverables.
Edit existing process documentation and lead monitoring and reporting.
Provide analysis and interpretation of information in response to requests from requestors and pursue greater data quality through identification of gaps and delivery of efficient solutions.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
3 years of pharmaceutical industry experience in a regulatory environment.
Experience with License Maintenance as well as overall R&D processes.
Direct experience with project planning & execution.
Preferred Qualifications :
If you have the following characteristics, it would be a plus :
Master’s degree or MBA
Experience working in a matrixed environment
Demonstrated ability to engage and influence senior stakeholders.