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 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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