Senior Regulatory Officer – Labelling / ‘Big Pharma’ Group

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.

Some Of Our Feedback

  • A fast-growing Biotech Company were struggling to find a Vice President, Global Regulatory Affairs and having engaged a major Executive Search firm in the USA had spent over 1 year looking for the right candidate without success. Within 8 weeks of requesting my help, we provided the company with 12 candidates, from which the ideal candidate was selected, who, over two years on, is still successfully operating within this role.

  • A leading Biopharma Company were looking for an Associate Director, Regulatory Strategy Team Lead for Emerging Markets, but had thus far failed to secure the right candidate. In fact, after 6 months of trying they’d only been able to secure an interview with one, less than ideal, candidate. Within 30 days of working with myself, a very suitable candidate was identified and started working for the company within 3 months. We provided the Biopharma Company with 11 excellent candidates to choose from.

  • A Pharmaceutical Company contacted me to find their new Head of Regulatory Affairs, to be based in a challenging location. Within 60 days of approaching me, after an intercontinental recruitment campaign, 6 candidates were identified and delivered. A suitable candidate was chosen and placed. The Company expressed their gratitude for having exceeded their expectations.

  • A newly created Vaccines organisation tasked Turner Regulatory Recruitment with finding a Head of Region, Senior Director, EU Regulatory Affairs. At the time, there were a number of Biotech/Vaccines companies seeking to fill similar positions; however, in spite of these challenging market conditions 13 candidates were identified and put forward from the ensuing short-listing process, one particular candidate was chosen, offered and accepted; this candidate is still happily in situ.

  • A well-established and commercially successful Biotech Company was having trouble in sourcing a Senior Director Regulatory CMC with a European/EMEA focus for their London Office. This organisation had been seeking to fill this role using numerous Agencies/Head-hunters for well over 6 months without success. Turner Regulatory Recruitment took a fresh and targeted approach to the role, identifying and delivering 8 excellent candidates. From the following interviewing process, not 1, but 2 candidates were offered, and both accepted.