Regulatory Affairs Senior Executive UK/Ire

An internationally leading pharmaceutical company is seeking to recruit a Regulatory Affairs Senior Executive UK/Ire to their office in London. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.

Job Responsibilities:

• Maintain existing, and obtaining new, marketing authorisation's in UK and Ireland for national, MRP, DCP and Centralised products in support of the company's commercial activities and strategy, ensuring conformance to national and EU Drug Laws.
• Ensure that the necessary regulatory support is provided to local, regional and global regulatory affairs functions and collaborate fully with other local and global functions including commercial teams to successfully execute business priorities.
• Provide regular updates to the Regulatory Affairs and Quality Manager on the status of ongoing projects/applications being handled by the Regulatory Affairs team.
• Prepare, compile, and submit UK/IE regulatory applications for national, MRP, and DCP products, including:
• Management of fee requests and oversight of regulatory agency invoices and statements, including annual fees.
• Preparation of submission documentation, including preparation of local product information and management of requests for mock-ups (ensure regulatory review of artworks, applying NPSA principles for injectable medicines).
• Liaison with publishing.
• Filing of regulatory submissions and approvals, both electronic and hard copy.
• Completion of post-submission actions (i.e. update of relevant quality and document management systems, notifications to commercial teams).
• Ensure that any regulatory commitments or requests for information are logged appropriately and responded to by the agreed deadline and answer routine correspondences on own initiative.
• Act as the regulatory contact point for local, international and global teams on UK/Irish regulatory matters:
• Manage direct interactions with local UK/IE regulatory authorities for national licenses, for the national phase of MRP/DCP procedures and in relation to local activities required for Centralised products (i.e. risk minimization materials).
• Ensure that regulatory requirements of UK & Ireland are fully represented in discussions at Global, Regional and Local levels.
• Build good relationships with internal and external stakeholders, particularly within Global Regulatory Affairs and at the Regulatory Authorities.
• Mentor and trainer for other team members, ensuring:
• oversight and review of draft submissions and execution of post-approval actions prepared by junior team members to ensure quality standards and compliance targets are met.
• training on key regulatory systems/processes
• sharing of best practice and intelligence gathered
• Support EU strategy on specific projects on development/marketed products.
• Oversee preparation of responses to periodic requests (e.g. tender support, HTA submissions, shortage notifications, unlicensed medicines requests, PSMF reviews).
• Provide launch readiness and other commercial project team support.
• Monitor the status of competitor marketing authorisation's as agreed with the local business.

Skills and Requirements:

• BSc/ in a scientific discipline; MSc preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven experience and relationship with UK or Ireland Regulatory Authorities.
• Experience of preparing and submitting post-marketing regulatory applications (i.e. variations, renewals, post-marketing commitment submissions, PSURs and other ad hoc activities as required),
• Experience of writing and updating comprehensible, clear, product information documents, including development of labelling, and leaflet artworks.
• Keep up to date with Regulatory intelligence and sharing accordingly.
• Contribute usefully to regulatory discussions.
• Experience of producing written regulatory communications with clarity, accuracy, and rigor.
• Knowledge of the Centralised procedure.
• Experience of working in a local affiliate regulatory affairs department.
• Experience of working within electronic regulatory tracking databases and document management systems.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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