Quality & Regulatory Specialist

Grifols; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive benefits package

Collaboration with local, regional and

Professional growth within a multinatl

Job summary

Grifols is seeking a Regulatory and Quality Specialist to lead regulatory affairs activities for India and neighboring markets, ensuring registrations, approvals and lifecycle management while supporting local QA and pharmacovigilance.

The role requires a degree in Pharmacy or Life Sciences, experience in regulatory affairs, and strong cross-functional collaboration skills to enable launches and portfolio maintenance within a multinational healthcare environment.

Qualifications

• Degree in Pharmacy, Life Sciences or a related scientific discipline.
• Experience in Regulatory Affairs within pharma/biotech/healthcare.
• Knowledge of regulatory submissions and interactions with health authorities, preferably in India and SAARC.
• Strong stakeholder management and organizational skills.
• Ability to work in cross-functional and multicultural environments.

Responsibilities

• Lead Regulatory Affairs activities in India and neighbouring markets including registrations, submissions, approvals, renewals and lifecycle management.
• Develop and execute regulatory strategies aligned with business objectives to support launches and portfolio maintenance.
• Ensure compliance with local QMS requirements and support audits, supplier qualifications and GDP activities.
• Support Pharmacovigilance as local backup contact, ensuring PV compliance and safety reporting.
• Collaborate with Commercial, Medical Affairs, Supply Chain, Finance and Global teams to support business growth while ensuring regulatory and quality compliance.

Skills

Regulatory affairs

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Regulatory intelligence

Quality management

Pharmacovigilance

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Veeva

SAP

TrackWise

Job description

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 opportunity 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 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.

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.

Grifols is an equal opportunity employer.

• Competitive benefits package.
• Opportunity to collaborate with local, regional and global teams.
• Professional growth within a multinational healthcare organization.