Regulatory Operations Officer |Negotiable
Regulatory
Permanent
South East

Regulatory Operations Officer

Additional Information

Location: High Wycombe
Salary: £38,000 – £41,000 + 3% Bonus
Hours: Monday to Friday 37.5hpw
Job Type: Permanent

Job purpose

* The function of the role holder is to support international regulatory team.
* Manage the day-to-day International Regulatory submission activities such as New registrations as per the strategic plan timelines, Variations, Renewals, tenders, PPQRs, customer/commercial queries etc.
* Responsible to perform the international regulatory impact assessment upon the receipt of the UK variation approval and update the relevant trackers.
* Responsible and accountable for the regulatory core dossier preparation, licence maintenance activity and licence approvals for the UK, EU and International markets (Middle East and North Africa (MENA), AFRICA and APAC)
* Duties include interfacing with regulatory agencies proactively to respond to RFIs rapidly and drive licence approvals as well as with multiple cross functional stakeholders and project teams in order to proactively plan, coordinate and procure specialty documentation and samples required to support international regulatory submissions.

This individual will be responsible for providing input, project related metrics, monthly highlights, troubleshooting documents and sample fulfilment issues and contributing to process and system enhancements.

Main Responsibilities and Duties

Teamwork
* 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 Date: September 18
* 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 be presented to cross-functional teams.

Planning/ Organisation
* Able to construct, support and manage high visibility project plans in support of assigned projects
* Able to prioritise work load and meet established goals and timelines per established regulatory strategy and plan.
* 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 appropriate information.
* Identify areas for improvement to systems, project plans and processes.
* Make quality decisions sometimes with incomplete information, whilst able to deal with uncertainty/risks and grasping the essence of the issue.

Experience and Qualifications

Educational Level
Bachelor’s Degree, or equivalent
Experience
3 years +
Professional Qualification

Pharmacy Background
Knowledge

– CTD modules
– Labelling requirements
– Submission of variations and renewals

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