Drug Regulatory Affairs Officer
il y a 3 semaines
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.
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