Regulatory Affairs Specialist Api'S (Active Pharmaceutical Ingredients)

buscojobs España; Málaga; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is looking for a Regulatory Affairs Specialist to ensure compliance and approval of Drug Master Files (DMFs) for Active Pharmaceutical Ingredients (APIs). The role involves managing submissions, advising on regulatory strategies, and ensuring quality and compliance for product development. Candidates should have at least 5 years of experience in Regulatory Affairs and a relevant scientific degree, along with proficiency in English technical writing.

Formación

• 5 years in Regulatory Affairs area related to Pharmaceutical registrations.
• High level of English at technical writing level.

Responsabilidades

• Prepare DMFs / dossiers ensuring safety and efficacy.
• Manage submission of DMFs / dossiers to health authorities.
• Participate in the launch of new APIs advising on regulatory strategies.

Conocimientos

Regulatory Affairs

Technical Writing

Compliance

Educación

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