Regulatory Affairs - Labeling and Pharmacovigilance (H/M)

Michael Page; Madrid; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A multinational healthcare company in Madrid is seeking a Regulatory Affairs professional to lead the preparation of regulatory documentation and ensure compliance with local regulations. The position involves coordinating with Pharmacovigilance teams, maintaining an adequate database for registrations, and reporting on system performance. Candidates should have a solid background in regulatory compliance and project management. The role offers a competitive salary, permanent contract, and opportunities for professional growth within the company.

Servicios

Competitive salary

Professional development and training programs

Supportive company culture

Formación

• Experience in regulatory affairs within the healthcare industry is preferred.
• Ability to manage multiple projects and meet deadlines.
• Strong knowledge of local regulations affecting pharmaceuticals.

Responsabilidades

• Lead preparation and review of regulatory documentation.
• Coordinate with the Pharmacovigilance team in projects.
• Ensure compliance with local regulatory requirements.
• Provide support in preparing labeling documents.
• Maintain regulatory documentation database.
• Report on regulatory processes and performance.

Conocimientos

Regulatory compliance

Pharmacovigilance

Document preparation

Project coordination

Attention to detail

Descripción del empleo

• Multinational Healthcare Company
• International project

This opportunity is with a large organization in the Healthcare industry that is known for its commitment to innovation and quality. With a strong presence in its field, the company offers a professional environment to thrive in regulatory affairs.

• Lead and coordinate the preparation and the review of SmPC, PIL, mockups, and ad prom material.
• Represent the RA team in Pharmacovigilance projects and meetings.
• Maintain and protect existing licenses in international, ensuring compliance with local regulations.
• Review and approve change control / design control impacting packaging and artworks to ensure regulatory compliance.
• Ensure that the pharmaceutical products sold in international meet the local regulatory requirements.
• Provide timely support when requested by these organizations in preparing necessary regulatory and labeling documents, submitting these documents in a timely manner and maintaining an adequate archiving system.
• Maintain the database in which all registrations made in these territories are documented.
• Report to his direct manager on the performance of the regulatory process system and registration timelines.
• Maintain knowledge of specific regulatory requirements for targeted markets.

• Competitive salary range.
• Permanent contract based in the north of Madrid.
• Opportunities to grow within the Multinational company.
• Professional development and training programs.
• Supportive company culture focused on innovation and quality.