Regulatory Affairs Specialist: Submissions & Compliance

SOMAÍ Pharmaceuticals LTD.; Portugal; Teletrabalho; EUR 30 000 - 50 000; Tempo integral

Resumo da oferta

SOMAÍ Pharmaceuticals LTD. is seeking a Regulatory Affairs Specialist in Lisboa to ensure regulatory compliance for products. Responsibilities include preparing and submitting submissions to regulatory authorities and reviewing technical documentation for product registrations. Candidates should have a degree in Pharmaceutical Sciences or related fields and demonstrate strong problem-solving and teamwork abilities. Immediate availability is preferred. The role may require a driver’s license and offers a collaborative environment for regulatory strategy development.

Qualificações

• Degree or Integrated Master’s in Pharmaceutical Sciences or related sciences.
• Strong focus on quality and compliance.
• Ability to work effectively in a team and solve problems.

Responsabilidades

• Prepare and submit regulatory submissions to authorities.
• Review technical documentation for product registrations.
• Support the authorization process for new products.
• Review and approve labeling texts and promotional materials.
• Contribute to product safety monitoring.
• Maintain regulatory files and manage archives.
• Provide regulatory support to other departments.
• Develop internal regulatory strategies and procedures.
• Communicate effectively with regulatory authorities.

Conhecimentos

Quality focus

Problem-solving orientation

Teamwork

Formação académica

Degree in Pharmaceutical Sciences or related fields

Descrição da oferta de emprego

SOMAÍ Pharmaceuticals LTD. is seeking a Regulatory Affairs Specialist in Lisboa to ensure regulatory compliance for products. Responsibilities include preparing and submitting submissions to regulatory authorities and reviewing technical documentation for product registrations. Candidates should have a degree in Pharmaceutical Sciences or related fields and demonstrate strong problem-solving and teamwork abilities. Immediate availability is preferred. The role may require a driver’s license and offers a collaborative environment for regulatory strategy development.