Regulatory Affairs Manager
Korea, KR
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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 global 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. |
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We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking a Regulatory Affairs Manager for our Diagnostic business.
What your responsibilities will be:
You will have the opportunity to:
- Plan and budget regulatory activities, analyzing industry trends and supporting commercial and clinical strategies.
- Prepare and manage regulatory submissions, clinical trial coordination, and license maintenance for medical devices, IVDs, and pharmaceuticals.
- Lead regulatory project management, including documentation, supplier oversight, and internal reporting.
- Handle post-market surveillance, pharmacoviglance, and regulatory communications, ensuring compliance and with local requirements.
- Support the local Quality Management System, ensuring GxP compliance, managing audits and addressing quality-related inquiries.
Who you are:
- You have a University Degree or higher in Biomedical, Biochemistry, Biology, Pharmacy or equivalent. Advanced knowledge or experience in molecular biology, immunology or hematology is added advantage.
- You have minimum 5 years of experience in a similar role.
- You have strong scientific understanding and ethical standards.
- You have excellent communication, relationship-building, and presentation skills.
- You speak fluent intermediate English.
What we offer:
This is a brilliant opportunity to join a dynamic and international Medical Affairs team within Grifols. You will report to the Associate Director of Medical Affairs France and collaborate closely with the European Medical Affairs structure.
Grifols values its employees as one of its greatest assets and is committed to fostering a professional environment that supports career development and personal growth.
For more information about Grifols, visit www.grifols.com. If you are interested in this exciting opportunity and meet the qualifications, we encourage you to apply!
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our recruitment process, please let us know when applying. We are here to help.
Grifols is an equal opportunity employer.
Contract of Employment: Permanent position.
Flexibility: Hybrid working model.
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Location: APAC : Korea : Korea:Korea