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Regulatory Compliance Officer
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About the Role
We are seeking a skilled REGULATORY AFFAIRS OFFICER to join our Regulatory Affairs Team at Labiana Health. As a key member of our team, you will be responsible for managing eSubmissions, participating in Life Cycle Management, and offering regulatory support to clients regarding CDMO and out-licensed products.
Main Responsibilities:
- Manage eSubmissions to ensure timely and accurate submission of documents.
- Participate in all Regulatory Affairs activities related to Life Cycle Management once products are authorized.
- Offer regulatory support to clients regarding CDMO and out-licensed products.
- Assess regulatory impact of internal change requests.
- Contribute regulatory insights during due diligence activities.
- Conduct regulatory intelligence to advise on regulations and guidelines for both internal and external customers.
Requirements:
- University degree in pharmacy or a science-related field.
- Minimum of 3 years in regulatory affairs within the pharmaceutical industry.
Skills:
- Strong expertise on CMC.
- Advanced in oral and written English.
- Advanced skills in Microsoft Office and eCTD manager.
- Knowledge of European pharmaceutical legislation, guidelines, procedures, and requirements.
- Proactive, possessing excellent communication, scientific, and writing skills.
- Team-oriented with a strong focus on customer service.
