Regulatory Affairs Specialist (M/F) - Sintra

2024-09-02 Sintra, Lisboa Saúde, Medicina, Enfermagem Ref: 248-000246-1 Funções - Handling of all post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications (MAA), Abbreviated New Drug Submissions (ANDSs), variations/supplements to current ANDA / MA / ANDS, Annual Reports and replying to deficiency letters according to the regulatory guidelines; - Evaluate Change Controls, issue/update New Registered Product form (NRP's), prepare product information variations/labelling supplements, provide information for Annual Product Review (APRs), creation and revision of internal SOPs and DHFs whenever applicable; - Support the site on the launch of new products, by performing all regulatory activities required; - Prepare, review and implement labelling; - Comply with the defined KPIs. Requisitos - Master's degree in Pharmaceutical Sciences (Minimum); - Experienced in EU Market Regulatory Affairs (Preferred); - 4-6 years of professional experience; - Responsibility, proactivity and teamwork; - Maintains awareness ofregulatory guidelines and updates; - Organization and planning capabilities; - Ability to work under pressure and to meet deadlines; - Good analytical and negotiation skills. Oferta - Direct contract with Client; - Salary adequate to thefunction and experience; - Life insurance;- Health insurance; - Annual Performance Bonus. Porque acreditamos no Talento sem etiquetas, estamos comprometidos com a não discriminação, promovendo a diversidade, a inclusão e a equidade no mercado de trabalho. #J-18808-Ljbffr