Quality & Regulatory Specialist

Grifols, S.A; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive benefits

Collaboration with global teams

Career growth opportunities

Job summary

Grifols is seeking a Regulatory and Quality Specialist to lead regulatory affairs activities for India and neighboring markets, ensuring registration, approvals, renewals and lifecycle management of the portfolio. The role also supports local quality assurance and pharmacovigilance to maintain compliance with regulations and company standards.

You will develop regulatory strategies, support product launches, tender activities and collaborate with Commercial, Medical Affairs, Supply Chain and

Qualifications

• 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.

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.

Skills

Regulatory affairs

Stakeholder management

Cross-functional collaboration

Communication

Education

Pharmacy or Life Sciences degree

Tools

Veeva

SAP

TrackWise

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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.