REGULATORY AFFAIRS SPECIALIST API's (Active Pharmaceutical Ingredients)

Bioiberica SAU; León; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa líder en la producción de Ingredientes Farmacéuticos Activos (API) busca un Especialista en Asuntos Regulatorios para asegurar la calidad y eficacia de sus productos. El candidato ideal tendrá experiencia en la preparación de DMFs y una sólida formación en ciencias, además de habilidades avanzadas en redacción técnica en inglés. Este profesional será responsable de interactuar con las autoridades sanitarias y asesorar a los departamentos comerciales en el proceso de regulación de nuevos productos.

Formación

• 5 años de experiencia en Asuntos Regulatorios.
• Nivel alto de inglés para escritura técnica.

Responsabilidades

• Preparar DMFs y garantizar la calidad y seguridad de los APIs.
• Gestionar la presentación de solicitudes ante las autoridades sanitarias.

Conocimientos

Conocimiento en normativa de DMFs

Comunicación técnica en inglés

Educación

B.Sc. en Biología, Bioquímica, Química, Farmacia o similar

Descripción del empleo

REGULATORY AFFAIRS SPECIALIST API's (Active Pharmaceutical Ingredients)

Job Area : R&D / Quality

Location : 1

Year : 2025

To contribute to the maintenance, growth and robustness of the Active Pharmaceutical Ingredient (API) sales business by preparing, presenting and monitoring the evaluation and approval by the health authorities of the Drug Master Files (DMF), dossiers or technical documentation corresponding to the APIs developed and manufactured by Bioiberica, in order to guarantee their quality, safety and efficacy.

RESPONSIBILITIES :

• Prepare the DMFs / dossiers of the APIs developed and manufactured in a way that ensures their safety, quality and efficacy.
• Manage the submission of DMFs / dossiers to health authorities or customers, as appropriate, and follow up on their evaluation and approval.
• Advise customers and Commercial Departments on any request regarding related DMFs / Dossiers.
• Apply and be aware of the regulations in force at all times governing DMFs / dossiers and other regulatory competencies relevant to their role.
• Perform the assessment of change controls affecting intermediates or APIs with potential regulatory impact, in order to maintain the regulatory status of the final products containing them.
• Manage the relevant changes or updates to registration dossiers, with Authorities and clients.
• Participate in projects that allow the launch of new APIs in the market, advising the team on the regulatory strategies that allow their approval.
• Collaborate, if required, in the preparation of different applications or procedures before the Public Administrations that affect your area of knowledge.
• Participate in the review and approval flow of advertising material created by the Marketing Department, to ensure that it is in line with the registered API and complies with the applicable regulations.

REQUIREMENTS :

• 5 years in the Regulatory Affairs area in the preparation of Pharmaceutical registrations / DMF.
• Bachelor of Science (Biology, Biochemistry, Chemistry, Pharmacy or similar).
• High level of English at technical writing level.

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