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Regulatory Affairs Specialist
hace 2 meses
Job Summary
Groupe Productlife is seeking a highly skilled Regulatory Affairs Specialist to join our team in Spain. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to ensure compliance with national and European guidelines.
Key Responsibilities
- Provide guidance and support to clients regarding regulatory submissions and requests in Spain.
- Contribute to the development of regulatory activities, including pre-licensing, new registration, and post-approval applications.
- Assist with the preparation and submission of documentation for marketing authorization applications (MAAs) and post-approval applications.
- Manage artwork generation, labeling, and creation/update of product information, including review of packaging texts and format review of Summary of Product Characteristics, Patient Information Leaflets, and labeling.
- Respond to internal requests for technical and regulatory information and ensure compliance with all regulatory processes.
- Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
- Use various software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data.
Requirements
- At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree.
- At least 5 years of experience in RA in a Pharmaceutical Company or Service Provider.
- ES LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well.
- Strong computer skills, including MS Office applications, data and document management systems.
- Experience in project management and new registrations of drug products.
What We Offer
Groupe Productlife offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing our employees with the resources and support they need to succeed.
