Regulatory Affairs Assistant

ProductLife Group is looking for a REGULATORY AFFAIRS ASSISTANT 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.

Regulatory Affairs Assistant

We are seeking for a Regulatory Affairs Assistant who will contribute to Regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre-licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.

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. Finish and/or other Nordic languages are a plus.

As a result of the reinforcement of the International Platform we are now seeking a Regulatory Affairs Assistant.

Responsibilities:

• Contribute to the creation of client administrative documents to be included in regulatory submissions;
• Compile regulatory dossiers in accordance with national requirements;
• Systems management and administration;
• Document and track regulatory submissions and regulatory authority approval;
• Provide regulatory support to clients and associate companies;
• Liaise with sponsor head-office and affiliate departments on regulatory issues;
• Liaise with external regulatory authorities as required;
• Provide review of packaging texts;
• Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (. QRD compliance check).

Requirements:

• Bachelor’s degree in a science related field;
• Minimum 1-year experience in a Regulatory Affairs Pharma products;
• This experience should include a proven understanding of the regulatory process and experience in medical affairs;
• Experience in promotional materials review (Medicinal Product, Medical Device) will be an added value;
• Experience in PV would constitute added value;
• Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel and good computer skills, with the ability to learn industry softwares’;
• Effective oral and written communication skills in English and French (written and verbal fluency);
• Additional knowledge of Arabic languages are a plus;
• Excellent organisational and interpersonal skills;
• Process orientated with good attention to detail;
• Ability to work well within a team.

Benefits:

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