Drug Regulatory Affairs Officer

Location: Paris, France

Company Overview:

This is an exciting opportunity to contribute to the expansion and success of a leading health and wellness company.

Job Description:

In this role, you will be responsible for ensuring regulatory compliance and managing regulatory submissions for the company’s products. Your key responsibilities will include:

• Verifying the regulatory compliance of product labelling for all products in your portfolio.
• Preparing and updating regulatory files, ensuring their submission for product registration, variations, or renewals.
• Contributing to regulatory monitoring and reporting within the company, offering independent scientific and regulatory expertise.
• Actively supporting projects related to marketing authorization variations and manufacturing transfers.
• Addressing medical information inquiries concerning products in your portfolio.

Experience Profile:

• You hold a Master’s degree
• You have at least 2-3 years of successful experience in regulatory affairs within the pharmaceutical industry, particularly in CMC.
• You possess a strong understanding of the regulatory and normative environment related to the pharmaceutical sector.
• You are a proactive and dynamic individual with excellent interpersonal skills.
• A good working knowledge of English (both written and spoken) is required.