Regulatory Manager RIM & Operations

Employer
Turner Regulatory
Location
Hertfordshire (GB)
Salary
Circa £60,000 basic, good bonus and leading benefits
Closing date
3 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

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

Regulatory Manager RIM & Operations is responsible for leading the Operations team focused on Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).

Additional responsibilities are:

  • Liaising with queries on xEVMPD data and reconcile xEVMPD data with the Affiliates
  • Provision of expertise during 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.

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.

Turner Regulatory Recruitment is a newly established Headhunter/Recruiter created due to demand from both clients and candidates for a fast, professional and ethical Regulatory Recruitment Service that delivers. Although a newly established company, our experience is significant, spanning 12 years. We focus purely on Regulatory Affairs positions across Pharmaceuticals, Biotechnology, CROs, Generics, OTC and Medical Devices, so if you are looking for specialist expertise in Regulatory recruitment, this is the company to contact. As we specialise only in Regulatory Affairs we have to be unsurpassed at what we do; the company aims to set new standards of Regulatory Affairs recruitment services and delivery, which we hope others will follow, thereby raising overall standards.

Our staff, headed by Julian Turner, has an unparalleled track-record of success in Regulatory placements over the past 12 years, and has transacted business for Pharmaceutical Companies, Biotech’s, CRO’s, Generics Companies, Consultancies, CRO’s, Contract Manufacturers, OTC/Consumer Care Companies and Medical Devices Companies.

Contact Us
  • 71-75 Shelton Street
  • Covent Garden
  • WC2H 9JQ
  • United Kingdom
  • 0203 695 9477
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert