Regulatory Submission Specialist
Due to our ongoing global expansion, we have a great opportunity for a Regulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis.
We are looking for someone who can autonomously carry on the work within the scope of their activities and interacts with the Direct Manager to define priorities and manages workload. The Regulatory Submissions Specialist contributes to the management and development of procedures related to the activities in which he/she is involved in and ensures that the outputs of their activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems.
Main tasks & responsibilities:
- Develops and maintains knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities.
- Manages adaptation of master documentation for submission (Informed Consent and any additional patient items such as patient emergency card, patient diary and questionnaires etc…) to local requirements.
- Manages activities associated with obtaining initial and amended central authority approvals from Competent Authorities (CAs), Central Ethics Committee (CECs), IRB and any other authorities
- Manages contract and budget negotiation/execution with sites/investigators/other parties involved as applicable.
- Prepares the financial agreement/addendum to the financial agreement/loan/assignment letter for an external structure and obtain the Sponsor/OPIS signatures for the shipment to the Site.
- Maintains tracking of regulatory, ethics and administrative submission and approval dates.
What we are looking for:
- Experience with CA and CEC submission, using combined ways of submission
- ICF customization;
- Contracts and budget negotiation,
- CTIS (The Clinical Trials Information System) experience - a new central way how EU submission are being processed
- Minimum 2 years’ experience in a pharmaceutical or Clinical Research Organization
- Good knowledge of ICH / GCP regulations / IRB
- Fluent in English
- Good planning, problem solving and organizational skills
What we offer:
We offer a competitive salary, bonuses, and other benefits together with the opportunity to develop your professional career with an expanding and growing international company.
Please read the information notice on the processing of personal data in the candidates’ information section of our company website.
Who we are:
OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.