Regulatory Affairs Manager

  • Full-time
  • Department: Clinical Delivery

Company Description

Founded in 1997 by two Medical Doctors, Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in executing complex trials for  new Rare Disease, Oncology and Neuroscience treatments.

Job Description

  • Assume responsibility to act as Lead RAM for a study, and be responsible for the regulatory management of that trial including line management for local Regulatory Associates 
  • Evaluate / summarize data; prepare and submit documentation related to clinical studies (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.) to the relevant regulatory authorities, 
  • Responsible for QC check of completed clinical trial submission package prior to dispatch to Sponsor for final review and maintenance and QC of Country (ies) TMF.
  • Review, collect and disseminate where appropriate all regulatory information related to Ethics applications in countries where responsible, including application forms, fees, specific requirements etc.
  • Evaluate, prepare and submit documentation to IRB/EC or Investigator (CTA, any amendments, end of study notifications, study progress reports, CSR submission etc.)  as appropriate, with assistance from Clinical Operations staff where applicable (e.g. local EC applications)
  • Primary point of contact for the Sponsor’s regulatory group. Responsible for requesting / receiving all Sponsor’s regulatory documentation to support the Clinical study application
  • Provide input to BD RFPs (with guidance from Head of Regulatory Affairs)
  • To contribute assessment and qualification of Ergomed vendors that supposed to provide regulatory associate services

 

Qualifications

  • Ideally degree qualified 
  • Extensive experience in a regulatory affairs team.
  • Extensive experience of clinical trial applications within North America
  • Ideally some experience of complex clinical trials.
  • Strong communication, organisational and numeracy skills.

 

Additional Information

Why Should You Apply?

  • You want be involved in a wide range of interesting projects and studies
  • You'd like your achievements and hard work to be recognised
  • You want to work for a growing company where there are opportunities for advancement
  • You'd like to work in a company that has a great reputation with its clients and employees.
  • Making a difference to people's lives matters to you
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