REGULATORY AFFAIRS AND PHARMACOVIGILANCE SPECIALIST

Skills/Experience:
• University degree in appropriate field: pharma, chemistry, biochemistry, medicine
• At least 2-3 years of relevant experience in Regulatory Affairs within the Pharmaceutical industry
• Knowledge of the National and EU regulatory framework
• Languages: Professional use of the English language; both written and oral.
Personal qualifications:
• Excellent interpersonal and communication skills
• High ethical standards
• Attention to detail
• Strong organizational skills

Regulatory affairs specialist responsibilities may include:
• Interface with regulatory agency
• Assist in developing procedures to ensure regulatory compliance
︃​︁︄︉​︂︃︇​︂︃︁• Facilitate identification and resolution of scientific and regulator issues with regulatory agency
• Remain current with Romanian/international regulations, and communicate information within the organization, (advising production and QC staff on regulatory requirements) including creating training materials (if necessary);
• Collecting and collating a wide range of information;
• Keeping up date with a company's product range;
• For new product licences and licence renewals/approvals:
o Provide with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning;
o Collect data and prepare submissions to the regulatory agency
o Developing and writing clear arguments and explanations;
o Preparing submissions of licence variations and renewals to strict deadlines;
o Monitoring and setting timelines;
• Offer support in writing clear, accessible product labels and patient information leaflets;

Infomed Fluids is a company specialized in manufacturing and trading pharmaceutical products intended for the parental therapy and emergency medicine.
Infomed Fluids is a branch of ACS DOBFAR INFO (Switzerland), branch of the renowned ACS DOBFAR HOLDING, which over the last 30 years has been taking a very important place on the international market by manufacturing antibiotics as: penicillin and cephalosporius.
Our days, Infomed Fluids is present on the European market as a company with ambitious projects and products of maximum quality.