Require Regulatory and Quality Specialist at Grifols

Grifols, S.A. is a global healthcare company and leading producer of plasma-derived medicines founded in Barcelona, Catalonia, Spain, in 1909. With a workforce of over 23,800 employees, Grifols serves more than 110 countries and regions and maintains a direct presence in over 30.

Post : Regulatory and Quality Specialist

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.

Job Description
• 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 Chain, Finance and Global teams to support business growth while maintaining full regulatory and quality compliance.

Candidate Profile
• Degree in Pharmacy, Life Sciences or a related scientific discipline.
• Experience in Regulatory Affairs within the pharmaceutical, biotechnology, medical device or healthcare industry.
• Knowledge of regulatory submissions, approvals and interactions with health authorities, preferably in India and SAARC countries.
• Strong stakeholder management, communication and organizational skills.
• Ability to work effectively in cross-functional and multicultural environments.
• Experience with regulatory and quality management tools such as Veeva, SAP, TrackWise or similar systems is considered a plus.
• Fluent Hindi and English.

Additional Information
Qualification : Degree in Pharmacy, Life Sciences
Location : Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
Req Id : 545050
End Date : 15th November 2026