Regulatory Affairs Manager



Kraków, Poland
Full Time
3y ago

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

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





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

·         Minimum 4 years of regulatory experience within pharmaceutical/CRO industry

·         Previous experience in managing clinical trials globally

·         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

·         Preferably experience in trials with ATMPs/GMOs



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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Onkar By: Onkar