Senior Regulatory Operations Officer
Location: High Wycombe
Salary: £40,000 – £45,000 + 3% Bonus
Hours: Monday to Friday 37.5hpw
Job Type: Permanent
- The function of the role holder is to run a publishing
- Manage the day-to-day Regulatory and publishing activities for the regulatory team,
- Provide regulatory operations support for Global regulatory submissions and agency responses.
- Maintain current regulatory folder structure for tracking regulatory
- Provide support to harmonise the company group Document Management
Duties may include working closely with the regulatory affairs team and project teams in order to proactively plan and coordinate global registration through the efficient preparation, management and tracking of regulatory documentation and systems.
Main Responsibilities and Duties
- Must be collaborative and able to influence change
- Must be flexible and strive for continuous improvement
- Able to work in a global environment with multiple and diverse cross-functional teams and subject matter experts/ corporate partners
- Cross-culturally competent and customer service oriented
- Must have good Time-Management skills
- Able to work independently and proactively search out solutions to challenges, by
- Obtaining data from multiple and diverse resources, required to support global regulatory submissions
- Require minimal supervision for day to day activities and project oversight/ execution
- Demonstrate initiative by providing input with respect to continuous improvement opportunities for tools, systems and processes
- Able to identify risk, with mitigations and resolutions to b e presented to cross-functional
- Able to construct, support and manage high visibility project plan s in support of assigned projects
- Able to prioritise work load and meet established goals and tim elines.
- Must track, coordinate and procure required documentation for global regulatory submissions.
Decision Making/ Impact
- Able to identify risk/ root cause and provide options for resolution to regulatory affairs team accordingly with minimal impact on registration timelines.
- Analytical skills required to interpret regulatory data in order to be able to verify data
- Accuracy and search out the app ropriate in formati
- Identify area s for improvement to system s, project plan s and processe
- Make high-quality decisions sometimes with incomplete information on, whilst able to deal with uncert ainty/ ri sks and grasping the essence of the issue.
Experience and Qualifications
Nees and eCTD related
-Regulatory publishing systems
-Document management system
-All phases of drug development and product life cycle process