Senior Regulatory Operations Officer
Location: High Wycombe
Salary: £45,000 – £50,000 + Bonus
Hours: Monday to Friday 37.5hpw
Job Type: Permanent
* The function of the role holder is to run a publishing system.
* 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 documentation.
* Provide support to harmonise the company group Document Management System.
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 teams.
* 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 formation.
* Identify area s for improvement to system s, project plan s and processes.
* 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
* Bachelor’s degree, or equivalent combination of education and experience
* Excellent written and oral communication, and listening skills
* Proficiency in publishing in both NeES and eCTD submissions and using related tools.
* Well-developed time management skills and demonstrated ability to manage complex and multiple assignments with tight deadlines
* Excellent IT skills with knowledge of regulatory publishing systems
* Excellent skills with knowledge of Microsoft tools (mainly Excel & PowerPoint presentation tools)
* Excellent skills for establishing, maintaining and improving technology infrastructures through the use of Metrics and Key Performance Indicators
* Strong attention to detail and accuracy
* Well-developed analytical and problem-solving skills (Ability to identify and understand complex issues and propose creative and achievable solutions)
* Ability to work independently and as part of a team
* Must have good people skills
* Keeps up to date with the intelligence for Regulatory operations
* Strong track record of Pharmaceutical industry experience in an operationally focused role within Regulatory Affairs
* The successful candidate will preferably have a minimum of 3 years direct experience in a comparable role in the pharmaceutical industry.
* Previous practical experience preparing, filing and maintaining medicinal product registrations in Europe and Rest of the World.
* Full understanding and working knowledge of all phases of drug development and product life cycle process.
* Ideally have set up a regulatory publishing system previously
* Ideally have set up Document Management System previously
* Knowledge of Smarind system will be advantageous