GRUPA NEUCA

Clinmed, part of NEUCA Group, having 13 years’ experience with investigational medicinal products and medical devices studies we have developed know-how to be very efficient in conducted projects. ClinMed’s extensive understanding of the IMP and medical device regulatory issues enables our clients to save time and money with their studies. Our medical device experts have U.S. FDA as well as European regulatory experience and are flexible to address wide variety client’s demands.

Regulatory Specialist

Miejsce pracy: Warszawa
Region: mazowieckie
Numer referencyjny: RS/10/2019/W

Opis stanowiska

Tasks:

  • coordinate efforts associated with the preparation of regulatory documents or submissions;
  • peer review, QA and/or checking, as appropriate, of documents prepared/received;
  • advise on regulatory aspects including protocols/other docuemnts related to submission and clinical trials;
  • plan and track designated project activities;
  • communicate with RA/EC regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review;
  • coordinate, prepare, advice or review regulatory submissions for domestic or international projects;
  • assist with the preparation of additional data/information requested by EC/RA;
  • interpret regulatory rules or rule changes;
  • determine the types of regulatory submissions or internal documentation that are required;
  • identify relevant guidance documents, law and international standards, or consensus standards and provide interpretive assistance;
  • maintain current knowledge base of existing and emerging regulations, standards, or guidance documents;
  • participate in regulatory and/or clinical trial project teams.

Wymagania

Requirements:

  • at least 1 year of experience in clinical trials;
  • very good knowledge of polish legal acts regarding clinical trials and UE regulations;
  • knowledge of ICH GCP, ISO 14155;
  • good English skills, both spoken and written,
  • the ability to evaluate and make independent decisions taking into account relative costs and benefits;
  • identifying complex problems;
  • very good time management;
  • excellent communication and interpersonal skills;
  • good computer skill.

Oferujemy

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. We offer job for full FTE based in Warsaw.