Regulatory and Quality Specialist Role at Grifols | Pharmacy Graduates Eligible
A rare chance has emerged for professionals in the pharmaceutical sector through this Grifols Regulatory Specialist opportunity in Gurgaon, India. This role offers the opportunity to contribute to healthcare improvements while ensuring regulatory compliance and quality assurance.
About the Company
Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. Established in 1909, it specializes in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions. Grifols is committed to fostering an inclusive environment that values diversity and equal employment opportunities.
- Location: Gurgaon, IN
- Contract Type: Regular Full-Time
- Area: Quality
- Req Id: 545050
In this Grifols Regulatory Specialist role, the focus 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.
Grifols Regulatory Specialist responsibilities
You will have the opportunity to:
- Responsible for Regulatory Affairs activities in India and neighboring 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.
Who you are
The requirements listed below are representative of the knowledge, skills, education, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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 in Hindi and English.
What we offer
This is a brilliant opportunity for a professional looking to build a career with a strong focus on Regulatory Affairs while gaining exposure to Quality Assurance and Pharmacovigilance within a global healthcare company. If interested, candidates are encouraged to apply.
- Competitive benefits package.
- Permanent employment contract.
- Opportunity to collaborate with local, regional, and global teams.
- Professional growth within a multinational healthcare organization.
Grifols is an equal opportunity employer, and qualified candidates interested in this Grifols Regulatory Specialist opportunity are encouraged to apply before the deadline to seize this opportunity in the healthcare sector.
