Descrição da Função

Do you have experience in EU Market Regulatory Affairs in the pharmaceutical sector? This offer is for you! We are currently recruiting for a client company in the pharmaceutical industry, located in Sintra.

Descrição/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 KPls.

Requisitos
- Masters degree in Pharmaceutical Sciences (Minimum); - Experienced in EU Market Regulatory Affairs (Preferred) - 4-6 years of professional experience - Responsibility, proactivity and team work - 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

Oferece-se
- Direct contract with Client - Salary adequate to the function and experience - Life insurance - Health insurance - Annual Performance Bonus


Clique aqui para se candidatar!