Grifols Hiring Regulatory and Quality Specialist (Pharmacovigilance)

Grifols Recruitment – Regulatory and Quality Specialist, Gurgaon

Grifols is inviting applications for the Regulatory and Quality Specialist position in Gurgaon, India. This full-time opportunity is suited to professionals with experience in pharmaceutical regulatory affairs, regulatory submissions, and quality assurance. The role also involves supporting local pharmacovigilance activities and ensuring compliance with Indian and regional regulatory requirements. Candidates with a Pharmacy or Life Sciences qualification, knowledge of regulatory authorities, and strong communication skills may find this opportunity relevant.

Job Overview

Company Overview

Grifols is a global healthcare company established in 1909. It specializes in plasma-derived medicines and transfusion medicine, developing, manufacturing, and marketing healthcare products and services in more than 110 countries and regions.

The company offers professionals an opportunity to collaborate with local, regional, and global teams while contributing to regulatory compliance and healthcare operations.

Job Role and Responsibilities

The Regulatory and Quality Specialist will lead Regulatory Affairs activities for India and neighbouring markets while supporting local Quality Assurance and Pharmacovigilance functions. The role focuses on product registration, regulatory compliance, quality systems, and lifecycle management.

Regulatory Affairs

• Manage product registrations, regulatory submissions, approvals, renewals, and lifecycle activities.

• Monitor regulatory developments and maintain regulatory intelligence.

• Liaise with health authorities in India and neighbouring markets.

• Develop and implement regulatory strategies aligned with business objectives.

• Support product launches, portfolio maintenance, pricing activities, and tender participation.

Quality Assurance

• Support compliance with local Quality Management System (QMS) requirements.

• Assist with audits and supplier qualification activities.

• Support Good Distribution Practice (GDP) activities.

• Oversee quality-related requirements for third-party logistics providers.

Pharmacovigilance

• Act as a local backup contact for Pharmacovigilance activities.

• Support compliance with local and global pharmacovigilance requirements.

• Assist with safety reporting and maintenance of pharmacovigilance procedures.

Cross-Functional Collaboration

• Work closely with Commercial, Medical Affairs, Supply Chain, Finance, and global teams.

• Support business growth while maintaining regulatory and quality compliance.

• Coordinate with relevant stakeholders in a multicultural working environment.

Eligibility & Qualifications

Applicants should meet the following requirements:

• Educational qualifications: B.Pharm, M.Pharm, Pharm.D, B.Sc. Life Sciences, M.Sc. Life Sciences, B.Sc. Biotechnology, M.Sc. Biotechnology, B.Sc. Microbiology, M.Sc. Microbiology, B.Sc. Biochemistry, M.Sc. Biochemistry, or another related scientific qualification.

• Regulatory Affairs experience: Professional experience in the pharmaceutical, biotechnology, medical device, or healthcare industry.

• Regulatory knowledge: Understanding of regulatory submissions, product approvals, and interactions with health authorities, preferably in India and SAARC countries.

• Communication: Strong stakeholder management, communication, and organizational skills.

• Language proficiency: Fluency in Hindi and English.

• Technical skills: Experience with Veeva, SAP, TrackWise, or similar regulatory and quality management systems is an advantage.

The employer specifies a degree in Pharmacy, Life Sciences, or a related scientific discipline. The individual courses listed above are examples of potentially relevant qualifications, not a confirmed employer-approved course list.

What Grifols Offers

• Competitive benefits package.

• Permanent employment contract.

• Collaboration with local, regional, and global teams.

• Professional development opportunities within a multinational healthcare organization.

• Exposure to Regulatory Affairs, Quality Assurance, and Pharmacovigilance functions.

How to Apply

Interested candidates can review the requirements and submit their application through the official Grifols careers portal.

Apply Online – Grifols Regulatory and Quality Specialist

Job Summary