Regulatory Affairs Senior Associate (M/F)

Gi Life Sciences is currently recruiting a Regulatory Affairs Senior Associate to work with one of our clients based in the Lisbon area. Our client is one of the biggest Biotech companies operating in Portugal, and they are currently looking to hire a RA Senior Associate for a temporary, 12 months' project.

Main Responsibilities:

The RA Officer will:

• Have the responsibility of ensuring rapid market access of the clients’ products and optimal support on products already on the market.
• Provide regulatory support through the entire product life cycle, including ensuring local labels are developed and maintained in line with local legislation and the clients' standards and procedures;
• Work with Regional and Global Study Operations (GSO) teams to support local planning and execution for In Vitro Devices' performance studies in accordance with national regulatory requirements;
• Provide input in development, post-approval and Life Cycle Management;
• Liaise with Regulatory Agencies and Local Operating Companies, provide Input in document and process development, and support Marketing Authorization Applications (MAA) for Portugal.

Requirements:

- University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;

- Minimum 2 years of relevant Regulatory experience;

- International team work experience is a plus;

• Project management skills will be valued;

• Oral & written communication skills;

• Organization & multi-tasking skills;

• Fluent in English;

• Knowledge of the regulatory environment, guidelines and practice of Portugal.

If you would like to apply, or know more about this position, please submit your CV through our portal. 

Os candidatos interessados, em cumprimento do definido no Regulamento (UE) 2016/679 (RGPD), são convidados a ler a política de privacidade em pt.gigroup.com > Política de Privacidade Candidatos

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