Regulatory and Quality Specialist

Grifols; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Grifols is seeking a Regulatory and Quality Specialist to lead Regulatory Affairs activities for India and neighboring markets, ensuring registration, approvals and lifecycle management of Grifols portfolios. The role also supports local Quality Assurance and Pharmacovigilance, ensuring compliance with regulations and company standards.

The incumbent will collaborate with Commercial, Medical Affairs, Supply Chain, Finance and Global teams to drive business growth while maintaining full

Qualifications

• Degree in Pharmacy, Life Sciences or related discipline.
• Experience in Regulatory Affairs in pharma, biotech, medical device or healthcare industries.
• Knowledge of regulatory submissions, approvals and interactions with health authorities (India & SAARC preferred).
• Fluent in Hindi and English.

Responsibilities

• Regulatory affairs activities in India and neighbouring markets, including product registrations, 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 and tender participation.
• Ensure QMS compliance, supporting audits, supplier qualifications, GDP activities and quality oversight of Third-Party Logistics providers.
• Support Pharmacovigilance activities as local backup contact, ensuring PV procedures compliance.
• Collaborate with Commercial, Medical Affairs, Supply Chain, Finance and Global teams to support growth while maintaining regulatory and quality compliance.

Skills

Stakeholder management

Communication

Organizational skills

Cross-functional teamwork

Regulatory submissions knowledge

Education

Pharmacy or Life Sciences degree

Tools

Veeva

SAP

TrackWise

Job description

Job Summary

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 Details

• Location: Gurgaon, IN
• Contract Type: Regular Full-Time
• Area: Quality

Responsibilities

• 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.

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 Hindi and English.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.