Asset Management Compliance Specialist

OPIS; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A global CRO is looking for a Regulatory Submissions Specialist to join their regulatory team remotely. The ideal candidate will manage regulatory submission activities, ensuring compliance with global and local requirements. The role demands fluency in English and strong planning and organizational skills. Experience in contract negotiation and procedural management will be advantageous in this dynamic and collaborative work environment. Join a team committed to excellence in clinical research.

Formación

• Fluent in English.
• Good planning, problem solving and organizational skills.

Responsabilidades

• Develops and maintains knowledge of global and local regulatory requirements.
• Manages contract and budget negotiation with applicable parties.
• Contributes to the management and development of procedures.

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.

Responsibilities

• Develops and maintains knowledge of global and local regulatory requirements and industry practice / guidelines for submission activities.
• Manages contract and budget negotiation / execution with sites / investigators / other parties involved as applicable.
• Contributes to the management and development of procedures related to the activities in which he / she is involved and ensures that the outputs of their activities meet the quality standards required by the company.

Qualifications

• Fluent in English.
• Good planning, problem solving and organizational skills.

About the Company

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.