29 Aug
|
GRIFOLS
|
Gurugram
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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.
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.
The focus of the Regulatory and Quality Specialist is to lead Regulatory Affairs activities for India and neighboring markets, ensuring the successful registration, approval, maintenance and lifecycle management of Grifols' portfolio. In addition, the role supports local Quality Assurance and Pharmacovigilance activities, ensuring compliance with applicable regulations and company standards.
What your main responsibilities will be
You will have the chance to:
Responsible for Regulatory Affairs activities in India and neighbouring markets, encompassing product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence, and liaison with Health Authorities.
Develop and execute regulatory strategies aligned with business objectives, supporting product launches, portfolio maintenance, pricing activities and tender participation.
Ensure compliance with local Quality Management System (QMS) requirements, supporting audits, supplier qualifications, GDP activities and quality oversight of Third-Party Logistics providers.
Support Pharmacovigilance activities as local backup contact, ensuring compliance with local and global PV requirements, safety reporting and maintenance of PV procedures.
Collaborate closely with Commercial, Medical Affairs, Supply
📌 Regulatory and Quality Specialist (Gurugram)
🏢 GRIFOLS
📍 Gurugram