Global Regulatory Affairs Coordinator

DDReg Pharma Pvt. Ltd.; Gurugram District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

DDReg Pharma Pvt. Ltd. is looking for a Global Regulatory Affairs Coordinator in Gurgaon, India.

You will support regulatory submission activities across worldwide markets and coordinate with cross-functional teams and global authorities. The ideal candidate will have 3+ years of experience and strong knowledge of EU, UK, and RoW frameworks. You will manage multiple regulatory activities in a fast-paced environment, ensuring timely submissions and high-quality documentation, with onsite work in

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
• Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of regional regulatory requirements and submission processes.
• Knowledge of EU, UK and RoW markets; Germany, Netherlands, Italy, and France knowledge is included.
• Regulatory Affairs certification is optional but preferred.

Responsibilities

• Maintain up-to-date knowledge of global regulatory guidelines and ensure compliance.
• Coordinate with cross-functional teams (Clinical, Quality, Manufacturing) to gather regulatory docs.
• Liaise with local affiliates/partners for country-specific regulatory requirements and document customization.
• Maintain regulatory intelligence databases covering EU, UK and RoW markets.
• Monitor regulatory requirements with focus on Germany, Netherlands, Italy, and France.
• Assist in preparation, maintenance, and tracking of regulatory documents.
• Support interactions with health authorities and respond to regulatory queries promptly.
• Contribute to development and implementation of regulatory strategies to facilitate approvals.
• Coordinate regulatory activities across internal and external stakeholders for timely submissions.
• Support multiple regulatory submissions while maintaining quality and compliance standards.

Skills

Global Regulatory Affairs

Regulatory Submissions

Regulatory Intelligence

EU Regulatory Affairs

UK Regulatory Affairs

RoW Regulatory Affairs

Health Authority Interaction

Regulatory Documentation

Regulatory Strategy

Submission Tracking

Cross-functional Coordination

Stakeholder Management

Regulatory Submission Software

MS Office

Education

Bachelor’s / Master’s degree in Pharmacy, Life Sciences, or a related field

Tools

Regulatory Submission Software

MS Office

Job description

Job Title: Global Regulatory Affairs Coordinator

Experience Required: Minimum 3 Years

Location: Gurgaon, Haryana, India (Onsite)

Department: Regulatory Affairs

About The Role

We are hiring a detail-driven Global Regulatory Affairs Coordinator to support regulatory submission activities across worldwide markets.

The role involves coordination with cross-functional teams, local affiliates/partners, and global regulatory authorities. The ideal candidate should have strong knowledge of regional regulatory frameworks, excellent attention to detail, strong communication skills, and the ability to manage multiple regulatory activities in a fast-paced environment.

Key Responsibilities

• Maintain up-to-date knowledge of global regulatory guidelines and ensure compliance.
• Coordinate with cross-functional teams, including Clinical, Quality, and Manufacturing, to gather necessary regulatory documentation.
• Liaise with local affiliates and partners for country-specific regulatory requirements and document customization.
• Maintain regulatory intelligence databases covering regional regulatory requirements across EU, UK, and Rest of World markets.
• Monitor regulatory requirements with a special focus on Germany, Netherlands, Italy, and France.
• Assist in the preparation, maintenance, and tracking of regulatory documents.
• Support interactions with health authorities and respond to regulatory queries promptly and accurately.
• Contribute to the development and implementation of regulatory strategies to facilitate product approvals.
• Coordinate regulatory activities across internal and external stakeholders to ensure timely completion of submissions.
• Support multiple regulatory submissions while maintaining quality and compliance standards.

Required Skills & Qualifications

• Bachelor’s / Master’s degree in Pharmacy, Life Sciences, or a related field.
• Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of regional regulatory requirements and submission processes.
• Knowledge of global regulatory frameworks, particularly EU, UK, and RoW markets.
• Understanding of regulatory requirements across Germany, Netherlands, Italy, and France.
• Regulatory Affairs certification is optional but preferred.
• Excellent written and verbal communication skills.
• Strong attention to detail with a focus on quality and compliance.
• Good problem-solving and coordination skills.
• Proficiency in regulatory submission software and MS Office applications.
• Ability to work in a fast-paced, deadline-driven environment.
• Strong collaborative and team-oriented approach.
• Ability to manage multiple submissions simultaneously and work effectively under pressure.

Key Skills

• Global Regulatory Affairs
• Regulatory Submissions
• Regulatory Intelligence
• EU Regulatory Affairs
• UK Regulatory Affairs
• RoW Regulatory Affairs
• Health Authority Interaction
• Regulatory Documentation
• Regulatory Strategy
• Submission Tracking
• Cross-functional Coordination
• Stakeholder Management
• Regulatory Submission Software
• MS Office

Behavioural Competencies

• Detail-oriented with a strong focus on quality and compliance.
• Strong team player with a collaborative mindset.
• Excellent coordination and communication skills.
• Ability to manage multiple priorities and submissions.
• Ability to work effectively under pressure and meet deadlines.

Why Join Us

• Growth opportunities within the Regulatory Affairs function.
• Exposure to global regulatory markets and international regulatory requirements.
• Learning and development opportunities.
• Opportunity to work with cross-functional and international teams.
• Better compensation and career growth opportunities.