Quality & Regulatory Specialist

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

Job summary

Jobtailor in India is seeking a Regulatory Affairs professional to lead registrations, submissions, approvals, renewals and lifecycle management across India and neighboring markets.

You will ensure Quality Management System compliance, support pharmacovigilance, audits, and collaborate with Commercial, Medical Affairs and Global teams to enable growth while maintaining regulatory excellence.

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.
• Fluent Hindi and English.

Responsibilities

• Lead Regulatory Affairs activities for India and neighboring markets, including product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence and liaison with Health Authorities.
• Develop and execute regulatory strategies supporting product launches, portfolio maintenance, pricing activities and tender participation.
• Ensure compliance with local Quality Management System requirements, supporting audits, supplier qualifications, GDP activities and quality oversight of Third-Party Logistics providers.
• Support Pharmacovigilance activities as local backup contact, including safety reporting and maintenance of PV procedures.
• Collaborate with Commercial, Medical Affairs, Supply Chain, Finance and Global teams to support business growth while maintaining regulatory and quality compliance.

Skills

Regulatory Submissions

Product Registrations

Lifecycle Management

Pharmacovigilance

Quality Oversight

Stakeholder Management

Cross-functional Collaboration

Regulatory Intelligence

Health Authority Liaison

Education

Bachelor's degree in Pharmacy/Life Sciences

Tools

Veeva

SAP

TrackWise

Job description

• Lead Regulatory Affairs activities for India and neighboring markets, including product registrations, regulatory submissions, approvals, renewals, lifecycle management, regulatory intelligence and liaison with Health Authorities.
• Develop and execute regulatory strategies supporting product launches, portfolio maintenance, pricing activities and tender participation.
• Ensure compliance with local Quality Management System requirements, supporting audits, supplier qualifications, GDP activities and quality oversight of Third-Party Logistics providers.
• Support Pharmacovigilance activities as local backup contact, including safety reporting and maintenance of PV procedures.
• Collaborate with Commercial, Medical Affairs, Supply Chain, Finance and Global teams to support business growth while maintaining regulatory and quality compliance.

Requirements

• 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.

Core Competencies

Demonstrates expertise in Regulatory Affairs, including product registrations, regulatory submissions, and compliance with Quality Management Systems. Proficient in stakeholder management and collaboration across cross-functional teams to support business growth and regulatory compliance.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Regulatory Submissions Knowledge
• Quality Management System Compliance
• Stakeholder Management Skills
• Fluent Hindi and English

ATS Optimization Keywords

Hard Skills

• Regulatory Submissions
• Product Registrations
• Lifecycle Management
• Pharmacovigilance
• Quality Oversight

Soft Skills

• Communication Skills
• Organizational Skills

Industry Keywords

• Pharmaceutical Industry
• Biotechnology
• Medical Device
• Healthcare
• Health Authorities

Tools & Technologies

• Veeva
• SAP
• TrackWise