Founded in 1997 by a Medical Doctor , 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 the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job summary:

• Exciting opportunities within a leading global CRO dedicated to the provision of specialized services to the pharma and biotech industry in the development of new drugs from early phase to complex late stage programs.
• Ergomed is looking for Regulatory Affairs professionals with in-depth Clinical Trials experience, who would like to expand their knowledge to full life cycle management including Orphan Drug Designations, Pediatric 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 a excellent written and communication skills in English as well as good understanding of clinical trials environment/ICH GCP.

KEY RESPONSIBILITIES:

• 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

SKILLS AND EXPERIENCE:

·         Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience

·         Minimum 2 years of regulatory experience within pharmaceutical/CRO industry

·         Previous experience in managing clinical trials in at least 2 European countries

·         Good planning and organizational skills

·         Good written and verbal communication skills to clearly and concisely present information

·         Good attention to detail

·         Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

·         Clear understanding of ICH GCP across all areas

·         Good knowledge of EU Clinical Trials Directive/Regulation

We are looking for regulatory affairs professionals at ALL levels from junior to senior/manager level.

We offer excellent chances to progress and develop. We are a company that promotes those that achieve with us. Our Global head of operations started out with us as a CTA!

We work on a global basis on interesting projects within rare diseases, oncology, and neurology.