Regulatory Affairs Specialist - Europe Cluster

EVA Pharma

We are seeking a detail-oriented and driven Regulatory Affairs Specialist to join our dynamic team.

The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.

Key Responsibilities:

• Prepare and submit regulatory applications and documentation to the appropriate authorities within Europe.
• Review and assess product labeling, promotional materials, and technical documentation for compliance with regulatory requirements.
• Maintain knowledge of current and evolving regulations in the pharmaceutical sector, particularly within the European Union.
• Act as the liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or issues.
• Support the development of regulatory strategies for new product registrations and life cycle management.

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• 1-3 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.
• Knowledge of EU regulatory frameworks, guidelines, and procedures.
• Excellent communication skills, both written and verbal, in English; proficiency in additional European languages is a plus.
• Highly organized with the ability to manage multiple projects and deadlines effectively.