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