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.
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:
- Master’s 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
Oferta:
- Direct contract with Client
- Salary adequate to the function and experience
- Life insurance
- Health insurance
- Annual Performance Bonus