Regulatory Officer (m/f)
- OPTIMAPHARM d.d.
- Adresa: Almeria Business Tower, Ulica grada Vukovara 284, 10 000 Zagreb
- Web: http://www.optimapharm.hr
Established in 2006, OPTIMAPHARM is a full service CRO (Contract Research Organization), that provides tailored solution and has a high-level expertise in managing trials across Europe, with an unrivalled access to patients in the emerging market of Eastern and South Eastern Europe. Our operational excellence and customer-focused approach has led to us achieving a 95% repeat business level.
Having offices in Western, Central and Eastern Europe, as well as having a network of preferred partners, OPTIMAPHARM is well qualified to manage trials in the US and Europe, supporting both the Biotech and Pharma companies in reaching large patient populations in various indications whilst achieving competitive start-up timelines at competitive prices.
OPTIMAPHARM's mission is to provide flexible, high standard and client focused services to pharmaceutical, biotechnology and medical devices companies in order to develop better medicines for people. We have on board the most experienced team of clinical research professionals in the region and we were named in 2018 one of the top 10 CRO’s in Europe.
Opis poslaWe are looking for our office based in Zagreb candidates for the position of:
Regulatory Officer (m/f).
Regulatory Officer is a member of the Regulatory and Safety Department that is primarily responsible to ensure successful compilation, submission, and maintenance of submissions/notifications to ethics committees and regulatory authorities in the frame of clinical studies, including safety reporting from clinical trials, in accordance with the applicable laws and regulations, as well as applicable Standard Operating Procedures (SOPs) and current Good Clinical Practice (GCP).
Regulatory Officer is responsible for set up and maintenance of a detailed overview of ethics and/or regulatory submission activities, including supplementary submission/notification status tracking of the approved studies in line with applicable regulations and ordinances.
Regulatory Officer is also responsible for review, preparation and negotiations of clinical trial agreements with health care institutions.
University degree, preferably in Pharmacy or medical and life sciences.
Experience and knowledge:
- Experience in clinical research within CRO and/or Biopharmaceutical environment is an advantage
- Knowledge of ICH GCP Guidelines as well as Ethics, Regulatory and Safety reporting requirements and relevant legislation both in the EU countries is preferred
- Strong interest in clinical research
- Fluent in local language and in English, both, written and verbal
- Computer proficiency is mandatory
Skills and personality:
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Affinity to work effectively and efficiently in a matrix environment
- Very good interpersonal skills, attention to details and reasoning ability
If you would be interested in joining Optimapharm team, please send your CV in English till 18 July 2019 the latest. Please note that only shortlisted candidates that meet the requirements will be contacted for further selection process
Visoka stručna sprema, Magistar struke
By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer opportunity to work on the international projects and to be member of international clinical research teams, competitive compensation package, a lot of training opportunities and flexible working hours.
Stalni radni odnos