Regulatory Affairs Specialist – Pharma

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Sanofi is a global healthcare leader committed to improving health and well-being worldwide. With a presence in over 100 countries, we innovate across a broad spectrum of therapies, including general medicines, specialty care, vaccines, and consumer healthcare. Our mission is to chase the miracles of science to improve people’s lives, fostering a culture of collaboration, excellence, and patient-centricity. Join our team in Huesca to contribute to cutting-edge pharmaceutical developments.

Descripción del Trabajo

We are seeking a dedicated and meticulous Regulatory Affairs Specialist to join our dynamic team in Huesca. In this crucial role, you will be responsible for ensuring that all pharmaceutical products comply with national and international regulatory guidelines, facilitating the timely approval and launch of our innovative medicines. This position involves preparing, submitting, and managing regulatory dossiers, interacting with health authorities, and providing expert regulatory guidance to internal teams.

Responsabilidades Clave

• Prepare and submit high-quality regulatory dossiers (MAAs, variations, renewals) to health authorities in compliance with applicable regulations (e.g., EMA, AEMPS).
• Maintain comprehensive knowledge of current and evolving regulatory requirements and guidelines, interpreting their impact on company products.
• Liaise effectively with national and international health authorities, responding to their queries and requests in a timely manner.
• Provide strategic regulatory advice and support to cross-functional teams, including R&D, manufacturing, quality assurance, and commercial.
• Manage and track regulatory submissions, approvals, and associated timelines.
• Ensure that all product labeling, packaging, and promotional materials comply with regulatory approvals.
• Participate in regulatory intelligence activities, monitoring changes in the regulatory landscape.
• Coordinate with external partners and consultants on regulatory matters when necessary.

Habilidades Requeridas

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific field.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory dossiers in Europe.
• Strong understanding of European pharmaceutical regulations (e.g., EU Directives, ICH guidelines).
• Excellent written and verbal communication skills in English and Spanish.
• Meticulous attention to detail and strong organizational skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in regulatory databases and document management systems.

Cualificaciones Preferidas

• Master's degree or Ph.D. in Regulatory Affairs or a related scientific discipline.
• Experience with specific therapeutic areas (e.g., oncology, immunology, rare diseases).
• Familiarity with electronic submission systems (eCTD).
• Prior experience interacting directly with AEMPS (Spanish Agency of Medicines and Medical Devices).

Ventajas y Beneficios

• Competitive annual salary and performance-based bonuses.
• Comprehensive health and dental insurance.
• Generous paid time off and holidays.
• Retirement savings plan with company match.
• Opportunities for professional development and career growth.
• Employee assistance program.
• Subsidized gym memberships and wellness programs.

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