Regulatory Affairs Specialist

EPM Scientific; Vitoria; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Spain is seeking a detail-oriented Senior Regulatory Associate to support the preparation and submission of high-quality regulatory documentation. Ideal candidates have 3+ years of experience in Regulatory Affairs and strong knowledge of electronic submission standards and tools. This position includes publishing and quality control of submissions, mentoring junior staff, and ensuring compliance with agency standards.

Formación

• 3+ years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of electronic submission standards and tools.
• Excellent communication and collaboration skills.

Responsabilidades

• Publish, dispatch, and archive regulatory submissions in agency-recommended formats.
• Ensure timely delivery of high-quality submissions aligned with standards.
• Format, hyperlink, and process submission-ready documents.

Conocimientos

Attention to detail

Regulatory submission experience

Communication skills

Collaboration skills

Proficiency in MS Word

Proficiency in Adobe Acrobat

Herramientas

Electronic submission standards

Publishing/validation platforms

Descripción del empleo

We're seeking a detail-oriented and proactive Senior Regulatory Associate to support the preparation and submission of high-quality regulatory documentation. This is a fantastic opportunity for professionals with 1-3 years of experience in Regulatory Affairs who are ready to take the next step in their career.

Key Responsibilities

• Publish, dispatch, and archive regulatory submissions in agency-recommended formats.
• Ensure timely delivery of compliant, high-quality submissions aligned with client and internal standards.
• Format, hyperlink, and process submission-ready documents using MS Word and Adobe Acrobat.
• Troubleshoot technical issues related to document formatting and publishing tools.
• Collaborate cross-functionally to plan, prepare, and perform quality control checks on submissions.
• Support regulatory audits and compliance activities.
• Maintain up-to-date knowledge of agency standards and submission procedures.
• Manage technical aspects and provide status updates for assigned submissions.
• Use publishing and validation tools effectively.
• Mentor junior staff and contribute to SOPs, work instructions, and training materials.

What We're Looking For

• Experience : 3+ years in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of electronic submission standards and tools.
• Proficiency in MS Word, Adobe Acrobat, and publishing / validation platforms.
• Excellent communication and collaboration skills.
• Ability to work independently and manage multiple priorities.