Ergomed is looking for a Regulatory Affairs professional with in-depth Clinical Trials experience, who would like to expand their knowledge to full life cycle management including Orphan Drug Designations, Paediatric Investigational Plans and Marketing Authorisation Applications to join our expanding team.
Opportunities are open to any geographical location, however candidates will be required to possess excellent written and communication skills in English as well as good understanding of clinical trials environment/ICH GCP.
· Prepare, collect, review 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 and IRB/EC and act on the Sponsors behalf in liaising with these authorities
· Act as Regulatory Lead for global clinical trials of low/medium/high complexity ensuring effective and rapid coordination and management of regulatory & ethics committee submission, striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
· Provide advice to Sponsor on addressing queries from regulatory authorities and IRB/EC, drafting responses and ensuring consistency in the responses provided within the same project
· Responsible for providing regulatory support to Ergomed Clinical Safety Department
· Evaluate, prepare and submit documentation related to Orphan Drug Designation Requests, PIPs and Market Authorization applications as requested with guidance from Head of Regulatory Affairs, other Senior Regulatory Managers having such experience and Quality Management / external consultant as appropriate
· Assist the Head of Regulatory Affairs in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets
· Prepare and/or contribute to the Regulatory Newsletter, maintain the regulatory intelligence and provide input to department work practices and other company initiatives