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 general 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
Prepare, review and manage complex submissions and follow up of chemistry/manufacturing and controls regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
Evaluate change requests for any of Grifols production sites for regulatory reporting requirements.
What Your Responsibilities Will Be
- Prepare,



review and manage complex submissions and follow up of chemistry/manufacturing and controls (CMC) regulatory activities, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Evaluate change requests for any of Grifols production sites for regulatory reporting requirements. Keep track of change requests in the appropriate database.
- Communicate with affiliates, outside companies and Health Authorities.
- Represent the regulatory function in cross-functional project teams as related to worldwide product registrations.
- Regulatory intelligence: search for applicable new regulations and guidelines from various Regulatory Authorities such as FDA, HC, EMA, etc.
- Keep track of CMC regulatory activities in the appropriate databases.
- Create and maintain regulatory strategy working practices and standard operating procedures.
- Support to other departments, affiliates and outside companies in any required

📌 Regulatory Cmc Strategy Sr Specialist (Cataluña)
🏢 Grifols
📍 Cataluña