Regulatory Affairs Specialist (M/F) - Sintra

2024-09-02 Sintra, Lisboa Saúde, Medicina, Enfermagem Ref: 248-000246-1Funções- 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 of regulatory 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 the function 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.
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