Nivel cariera

Middle (2-5 ani)

Limbi vorbite

engleză, română

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ProductLife Group is looking for a REGULATORY AFFAIRS OFFICER LATAM in Cluj-Napoca!

 

ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.

 We are seeking for a REGULATORY AFFAIRS OFFICER – LATAM who will contribute to the implementation of the overall regulatory strategy related to the registration and Life Cycle Management of product portfolio (medicines) and who will support local regulatory partners and liaise with client(s) in corresponding regulatory activities.

 We are looking for someone with proven understanding of the regulatory process of the pharmaceutical industry, with excellent organisational and interpersonal skills, with ability to work and interact smoothly within an international team. For this role we are seeking a professional with excellent communication skills in English.  Spanish and/or French is a plus.

 

Job Description:

Under the monitoring of the RA Hub Leader within the Latam team, your missions are:

  • Supervising and coordinating the regulatory activities in compliance with national requirements;
  • Providing regulatory support to and liaise with clients, associates and our local partners;
  • Providing on-going regulatory advice to Project team/Dossier Manager to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet the objectives.
  • Ensuring the delivery of documents for regulatory activities performed on the RA Hub in time; Regulatory activities include new registration and post approval regulatory submissions;
  • Obtaining regulatory approvals;
  • Reviewing format and content of the texts related to packaging, summaries of product characteristics, labelling and records;
  • Reviewing tasks, providing support and mentoring Regulatory Affairs Assistants;
  • Ensuring that invoicing is correctly set in PLG tools. Validating invoices of local partners;
  • Performing data entry (time reporting) in PLG tools for KPI and metric measurements for regulatory services supplied and supervise data entry of Hub RA assistants.
  • Documenting and tracking regulatory submissions and approvals in internal systems.

 Requirements:

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience (proven understanding of the regulatory processes);
  • 2-years’ experience in a regulatory affairs department;
  • Experienced in Latam or international regulatory affairs registration and related fields;
  • Fluent in English (spoken and written) for daily contacts with local partners and clients. Spanish and/or French are a plus;
  • Excellent project management skills and the ability to work well within a team;
  • Excellent organisational and interpersonal skills;
  • Result driven attitude;
  • Versatile and autonomous;
  • Rigorous and pragmatic.

 Benefits:

  • Full training on the job and external courses will be provided;
  • Competitive salary package;
  • Dynamic environment with opportunities for advancement within the company or the wider group;
  • International and growing company;
  • Flexible working environment;
  • Health insurance;
  • Meal tickets.