REGULATORY AFFAIRS SPECIALIST API's (Active Pharmaceutical Ingredients)

Bioiberica SAU; Esplugues de Llobregat; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Regulatory Affairs Specialist to enhance the robustness of its Active Pharmaceutical Ingredient sales. This role involves preparing and managing Drug Master Files and ensuring compliance with health regulations. The successful candidate will play a critical role in advising on regulatory strategies and collaborating with various departments to ensure product quality and efficacy. Join a dynamic team where your expertise will contribute to the growth of innovative pharmaceutical solutions that prioritize safety and effectiveness.

Formación

• 5 years of experience in Regulatory Affairs for Pharmaceutical registrations.
• Strong technical writing skills in English.

Responsabilidades

• Prepare DMFs/dossiers ensuring safety, quality, and efficacy.
• Manage submissions to health authorities and follow up on approvals.
• Advise on regulatory strategies for new API launches.

Conocimientos

Regulatory Affairs

Technical Writing

Pharmaceutical Registrations

Educación

Bachelor of Science (Biology, Biochemistry, Chemistry, Pharmacy)

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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