Regulatory Affairs Specialist (España)

Regulatory Affairs Specialist (España)

02 oct
|
Grifols Shared Services North America
|
España

02 oct

Grifols Shared Services North America

España

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a integral healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.
Mission
Ensuring compliance of the priority plan, as well as coordination of compilation, submission and following up of product registration and/or renewal and/or changes/variations dossiers, and any other regulatory documentation, within the company timelines. Determine and execute actions necessary for licenses and regulatory procedures are in compliance with domestic and international licensing requirements




What your responsibilities will be
- Assess and define worldwide regulatory strategies for product registrations, renewals, and lifecycle management activities across assigned products and markets.
- Review, prepare, and submit regulatory dossiers for new registrations, renewals, variations, and other post-approval changes, ensuring compliance with applicable regulations.
- Prepare, review, and coordinate responses to Health Authority questions and requests within established timelines.
- Manage and coordinate the adaptation of product licenses to current regulatory requirements and evolving legislation.
- Coordinate and approve packaging materials and labeling documentation, ensuring regulatory compliance and alignment with local market requirements.
- Organize, coordinate, and supervise the work of Regulatory Affairs Technicians, ensuring the timely and high-quality execution of assigned activit

📌 Regulatory Affairs Specialist (España)
🏢 Grifols Shared Services North America
📍 España

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