Senior Regulatory Affairs Specialist Consultant (OTC Products) - Remote

Overview

The Senior Regulatory Affairs Specialist Consultant will work remotely in Denmark for a global CRO, focusing on over-the-counter (OTC) pharmaceuticals, ensuring compliance with local regulations and managing product registrations.

In Short

• Work independently to provide regulatory input and guidance.
• Assess quality and clinical documentation for submissions.
• Prepare and submit regulatory submissions.
• Monitor regulatory authority review processes.
• Maintain compliance with local regulations.
• Participate in audits and inspections.
• Provide regulatory assessment for product claims.
• Ensure all products comply with quality system requirements.
• Identify process improvement opportunities.
• Communicate regulatory changes to management.

Requirements

• Relevant Bachelor's Degree or higher.
• 6+ years of related regulatory experience.
• Expertise in Regulatory classifications including Medicinal Products.
• Knowledge of regulatory frameworks and environments.
• Solid understanding of regulatory/medical/safety/quality requirements.
• Full proficiency in Danish and English.

Benefits

• Opportunity to work with a global CRO.
• Supportive company culture focused on professional development.
• Engagement in a high-trust environment with clients.
• Access to continuous training and development.
• Work on impactful projects in consumer health.