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 robust knowledge of regional regulatory frameworks, excellent attention to detail, strong communication skills, and the ability to manage multiple regulatory activities in a rapid-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.
Solid understanding of regional regulatory requ

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