Regulatory Affairs Specialist - Sintra [* ]

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 KPIs.
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!

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