Regulatory Affairs Specialist – Pharma

Acerca de la Empresa

Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At Bayer, we’re dedicated to innovation and sustainability, working to solve some of the world’s most pressing challenges in medicine and food supply. Join a team where your work has a real impact on people’s health.

Descripción del Trabajo

We are seeking a diligent and experienced Regulatory Affairs Specialist to join our Pharmaceuticals team in Malaga. This role is crucial for ensuring that our innovative pharmaceutical products comply with all relevant national and international regulations, facilitating their timely approval and market access. You will play a key role in preparing and submitting regulatory dossiers, interacting with health authorities, and maintaining compliance throughout the product lifecycle.

Responsabilidades Clave

• Prepare, review, and submit high-quality regulatory dossiers (e.g., MAAs, variations, renewals) to health authorities in accordance with applicable guidelines and deadlines.
• Develop and implement regulatory strategies for new product registrations and lifecycle management activities.
• Act as a primary contact point and liaison with national and international health authorities, responding to queries and managing communications effectively.
• Monitor and interpret new and evolving regulatory requirements and guidance documents, assessing their impact on Bayer's products and business.
• Provide expert regulatory advice and support to internal project teams (e.g., R&D, Clinical, Marketing) to ensure regulatory compliance throughout product development and commercialization.
• Manage and maintain regulatory databases and documentation systems, ensuring accuracy and audit-readiness.
• Participate in regulatory intelligence activities, including competitor analysis and industry best practices.

Habilidades Requeridas

• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• In-depth knowledge of European and Spanish pharmaceutical regulations (e.g., EMA, AEMPS guidelines).
• Proven experience in preparing and submitting regulatory dossiers (e.g., CTD/eCTD format).
• Excellent written and verbal communication skills in both English and Spanish.
• Strong analytical skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.

Cualificaciones Preferidas

• Master's degree or PhD in Regulatory Affairs or a related field.
• Experience with specific therapeutic areas (e.g., Cardiology, Oncology, Women's Health).
• Prior experience in regulatory strategy development for global markets.
• Familiarity with electronic submission systems and document management tools.

Ventajas y Beneficios

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Generous paid time off and holiday schedule.
• Company pension plan with employer contributions.
• Opportunities for professional development and continuous learning.
• Employee assistance program.
• Dynamic and inclusive work environment with a focus on innovation.

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