Senior Regulatory Officer - Labelling

This outstanding Labelling opportunity could represent the next stage in your career. European and Global Labelling Projects!! This is a superb Labelling role - you will operate as a Senior Regulatory Officer - Labelling: this is working for a newly established Pharma/Generics Company based in a desirable part of the Home Counties North.

• Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance, and templates, etc.
• Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data. As required, this includes locating and confirming the validity of such information.
• Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC, and relevant Labelling requirements.
• Maintaining Company Core Data Sheets and local labelling deviations.
• Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
• Working with Global Product Safety and Risk Management - Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the
• Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations.
• As required, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts.

Support Brand Leader monitoring process. Working knowledge of All Labelling changes throughout the Lifecycle. Company Core Data Sheets (CCDS); good working knowledge of Type Ia, Ib and II Variations, PIL's and SmPC's. Solid experience in Packaging & Artwork.

The remit is across the pipeline incorporating Registrations and Post marketing - the candidate will need a reasonable understanding of general Regulatory Affairs and will collaborate regularly with European and International Regulatory Teams.

The candidate will have expertise in Regulatory Strategy, Tactics, and Implementation within a Labelling context, particularly in European territories.

The company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day management of Labelling Projects. The candidate will need to have a substantial background in general Labelling issues - Prescribing Information, CCDS etc.

A demonstrable working relationship with the major Regulatory Agencies would be an advantage in terms of company representation.

The successful candidate will possess a solid Regulatory Labelling background within Pharmaceutical of at least 3+ years.

This position is based North of London; the role and may require some travel, as necessary.

A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other benefits.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application by clicking Apply Now.