Head of Regulatory Affairs and Pharmacovigilance - Vila Real de Santo António

Descrição: 

We are recruiting a Head of Regulatory Affairs and Pharmacovigilance for a company of cultivation and processing of medicinal Cannabis, with activity in Castro Marim and Vila Real de Santo António (Faro).

O que terás de fazer

- Responsible for ensuring the correct management and approval of orders for new products and materials after document verification, proper registration in the market and materials, renew and keep up to date records and codifications, following the procedures established by the Competent Authorities and adopted by the company;

- Carry out all activities related to the registration of cannabis plant-based preparations, medicines, medical devices, cosmetic and body care products and food supplements, namely in the submission, management and filing of regulatory processes, in the monitoring and maintenance of the cycle of product life and ensuring regulatory compliance and compliance with applicable legislation throughout the process;

- Develop regulatory strategies, make contacts and collaborate with Competent Authorities and other Regulatory Entities, and carry out all activities within the scope of Pharmacovigilance and Surveillance of Health Products;

- Regulatory support and design of strategies for product registration in different markets/countries in accordance with local legislation and submission requirements in the exporting countries in which the company operate;

- Adaptation of the dossiers in accordance with the submission requirements of the exporting countries, their submission and maintenance of the respective marketing authorizations.

O que precisas de garantir

- Consolidated experience in the area of Pharmaceutical Regulation;

- Degree in Pharmaceutical Sciences, with specialization in Regulatory Affairs;

- English language (Proficient);

- Experience in using ERP system;

- Knowledge of GMP standards;

- Good communication and negotiation skills;

- Analytical capacity, organized and systematic.

O que terás de fazer

- Responsible for ensuring the correct management and approval of orders for new products and materials after document verification, proper registration in the market and materials, renew and keep up to date records and codifications, following the procedures established by the Competent Authorities and adopted by the company;

- Carry out all activities related to the registration of cannabis plant-based preparations, medicines, medical devices, cosmetic and body care products and food supplements, namely in the submission, management and filing of regulatory processes, in the monitoring and maintenance of the cycle of product life and ensuring regulatory compliance and compliance with applicable legislation throughout the process;

- Develop regulatory strategies, make contacts and collaborate with Competent Authorities and other Regulatory Entities, and carry out all activities within the scope of Pharmacovigilance and Surveillance of Health Products;

- Regulatory support and design of strategies for product registration in different markets/countries in accordance with local legislation and submission requirements in the exporting countries in which the company operate;

- Adaptation of the dossiers in accordance with the submission requirements of the exporting countries, their submission and maintenance of the respective marketing authorizations.

O que precisas de garantir

- Consolidated experience in the area of Pharmaceutical Regulation;

- Degree in Pharmaceutical Sciences, with specialization in Regulatory Affairs;

- English language (Proficient);

- Experience in using ERP system;

- Knowledge of GMP standards;

- Good communication and negotiation skills;

- Analytical capacity, organized and systematic.