• Multinational Healthcare Company
• International project

¿Dónde vas a trabajar?

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.

Descripción

• 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.

¿A quién buscamos (H/M/D)?

• Life science degree.
• At least 2 of experience in regulatory labeling and pharmacovigilance in the pharmaceutical industry.
• Strong experience in labeling, experience in the preparation and the review of CTD is a plus.
• Knowledge of drug pharmaceutical requirements (clinical studies, pharmacovigilance, variations, renewals).
• An advances English level is a must.

¿Cuáles son tus beneficios?

• 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.