Senior Regulatory Affairs Specialist Consultant - OTC products at ClinChoice

ClinChoice is seeking a Senior Regulatory Affairs Specialist Consultant with a focus on over-the-counter (OTC) Pharmaceuticals to work with one of their Consumer Health partners. This role is a 12-month contract position based in Denmark and offers a remote work option.

The Senior Regulatory Affairs Specialist will provide regulatory input and technical guidance on local regulatory requirements to product development teams. He will assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant. The specialist will prepare and submit regulatory submissions, monitor the progress of the regulatory authority review process.

The Senior Regulatory Affairs Specialist also ensure compliance with local regulations and quality system requirements for all products. He will participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.

Responsibilities include:

• Providing regulatory input and technical guidance on local regulatory requirements to product development teams.
• Assessing the acceptability of quality, preclinical and clinical documentation.
• Preparing and submitting regulatory submissions.
• Monitoring the progress of the regulatory authority review process.
• Ensuring products comply with local regulatory and quality system requirements.

Requirements include:

• Relevant Bachelor's Degree or higher.
• 6+ years related regulatory experience.
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Medical Devices and Food Supplements.
• Knowledge of regulatory frameworks and external environments.
• Full Proficiency in Danish and English.

The job offers:

• REMOTE option in DENMARK