Regulatory Affairs Specialist – English Speaking Pharma

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Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. We are committed to innovation, sustainability, and making a positive impact on society.

Descripción del Trabajo

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical team in Adeje, Canary Islands. The successful candidate will be responsible for ensuring the compliance of our pharmaceutical products with relevant national and international regulations, with a strong focus on English-speaking regulatory bodies and documentation. This role requires excellent communication skills in English and a solid understanding of pharmaceutical regulatory processes.

Responsabilidades Clave

• Prepare, submit, and manage regulatory submissions (e.g., Marketing Authorization Applications, variations, renewals) for pharmaceutical products in various markets, with a focus on English-language dossiers.
• Ensure all regulatory activities comply with global and local regulations, including EMA, FDA, and national health authorities.
• Review and approve labeling, promotional materials, and product information to ensure regulatory compliance.
• Act as a key contact point for regulatory authorities and internal stakeholders on regulatory matters.
• Monitor changes in regulatory landscapes and communicate their impact to relevant departments.
• Participate in regulatory strategy development and provide expert advice on regulatory requirements for new product development.
• Maintain and update regulatory databases and tracking systems.

Habilidades Requeridas

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Excellent written and verbal communication skills in English (C1/C2 level).
• Strong understanding of pharmaceutical regulatory requirements (e.g., EU regulations, ICH guidelines).
• Proven ability to prepare and manage complex regulatory submissions.
• Attention to detail and strong organizational skills.
• Ability to work effectively in a cross-functional team environment.

Cualificaciones Preferidas

• Master's degree or PhD in Regulatory Affairs or a related scientific discipline.
• Experience with specific regulatory software and electronic submission systems.
• Proficiency in Spanish or another European language.
• Knowledge of global regulatory requirements beyond Europe.

Ventajas y Beneficios

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Retirement savings plan with company match.
• Opportunities for professional development and career growth.
• Access to wellness programs and employee assistance.
• Modern office facilities in a vibrant location.

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