Regulatory Affairs Specialist (M/F) - Sintra [248-000246-1] Sintra

Regulatory Affairs Specialist (M/F) - Sintra [248-000246-1]
Sintra
Sintra, Lisboa, Portugal

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