Regulatory Submission Specialist

OPIS s.r.l.; A distancia; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

A leading international clinical research organization is seeking a Regulatory Submissions Specialist to join their expanding team. The successful candidate will handle regulatory requirements and ensure compliance while managing documentation and approvals from various authorities. Ideal candidates will have at least 2 years of experience in a pharmaceutical or clinical research setting, be fluent in English, and possess strong organizational skills. This role offers competitive salary and benefits, alongside the chance to advance within the company.

Servicios

Competitive salary

Bonuses

Career development opportunities

Formación

• Minimum 2 years’ experience in a pharmaceutical or Clinical Research Organization.
• Strong understanding of regulatory submission processes.

Responsabilidades

• Develops and maintains knowledge of regulatory requirements.
• Manages adaptation of master documentation for submission.
• Obtains approvals from Competent Authorities and Ethics Committees.
• Negotiates contracts and budgets with sites and investigators.
• Prepares financial agreements for external structures.
• Maintains tracking of submission and approval dates.

Conocimientos

Experience with CA and CEC submission

Contracts and budget negotiation experience

CTIS experience

Good knowledge of ICH/GCP regulations

Fluent in English

Good planning skills

Good problem solving skills

Good organizational skills

Descripción del empleo

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.

What you’ll do

• 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.

Qualifications

• Experience with CA and CEC submission, using combined ways of submission ICF customization.
• Contracts and budget negotiation experience.
• CTIS (The Clinical Trials Information System) experience – a new central way how EU submissions 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.

Benefits

• Competitive salary.
• Bonuses.
• 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.