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.
Location
Gurgaon, Haryana, India (Onsite)
Apply
Interested candidates who meet the above requirements are encouraged to apply through the application form.
Experience Required: Minimum 3 Years
Location: Gurgaon, Haryana, India (Onsite)
Apply via: career.ddreg.in