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REMOTE WORKING / Regulatory Manager RIM & Operations (Regulatory Information Management) / IDMP / Large Pharma Group

Regulatory Manager RIM & Operations (Regulatory Information Management) – this desirable role is for a Large Pharma in North London/Hertfordshire, but Remote Working is offered.

This role is responsible for leading the Operations team focused on IDMP/Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).

Additional responsibilities are:

  • Liaising with queries on IDMP/xEVMPD data and reconcile xEVMPD data with the Affiliates
  • Provision of expertise during IDMP/xEVMPD audits/inspections
  • Generate, monitor, and ensure adherence to compliance metrics and Key Performance Indicators.
  • Provide reports to senior leadership/stakeholders
  • Discuss and resolve annual PV Fee Advice Note review with European Affiliates and accordingly adjust the xEVMPD database
  • Maintain SOP’s
  • Maintain an in-depth knowledge of xEVMPD, IDMP, SPOR, TOM, etc.; participate in external working teams (Health Authorities, Industry Forums, etc.); Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of any potential impacts
  • Ensure all necessary Training and Mentoring for Staff is in place and for the development of the Team
  • Appropriate Assessment of Staff in line with their development and responsibilities
  • Support of internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and/or improved IT solutions, business processes or tools
  • Successfully operate within multi-functional teams

Experience you will need for this position:

  • Life Science Degree
  • In-depth knowledge and understanding of pharmaceutical science processes and standards, including xEVMPD, ISO IDMP, SPOR, Standard Terms etc. Understanding of Regulatory Life-cycle management.
  • Experience using and administrating xEVMPD
  • Team Management
  • Working in Cross-functional Teams
  • An eye for detail
  • Must be proficient in Microsoft Word and Excel

A highly competitive salary package including good bonus and leading benefits awaits the successful candidate.

Remote Working offered.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07 447 977 330, or by julian@turnerregulatory.com, or apply 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.