Regulatory Operations Officer |Negotiable
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

* 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
3 years +
Professional Qualification

Pharmacy Background

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

If you are applying for the first time, please complete all fields below

Already registered with Sensible Staffing? Just enter your name, contact number and email.


Do you know someone who you think will be ideal for this position?

Complete the simple form below to send these details to your friend.

Sensible Staffing are fully committed to protecting any personal information that you choose to share with us via our website or through any means of correspondence.

What information do we collect?

We will collect and retain any personal data that you choose to send us using the online forms on our website. This information will only be used in accordance with our privacy policy and to provide you with a service or to answer your enquiry.

Sensible Staffing is part of the Pario Group of companies. At no stage will we disclose your information to a third party company outside of the Pario Group of companies and will use the appropriate security measures to ensure that all data remains private.

This also applies to any correspondence made by fax, phone or email.

Website Statistics

We track all visits to our website so that we can monitor usage and preferences to help us provide a better service and online experience for our users. Information we collect relates to referral websites, search engines and your personal IP address. We do not use this information to identify you as an individual and you will remain anonymous.


Cookies are small files stored within your web browser from our website. Cookies do not collect or contain any personal information about you nor do they allow us to access your computer in any way, shape or form.

We use cookies to identify website usage and for statistical and analytical purposes only. All information is collected lawfully and in accordance with the Data Protection Act 1998.

Your Rights

Please note that in agreeing to share these details you have not forfeited your rights as outlined under the Data Protection Act 1998.