DDReg Pharma is hiring for the position of Global Regulatory Affairs Coordinator for its Regulatory Affairs team in Gurgaon, Haryana. This full-time onsite opportunity is suitable for experienced Regulatory Affairs professionals with a background in Pharmacy, Life Sciences, or related disciplines.
Candidates with at least 3 years of pharmaceutical Regulatory Affairs experience and knowledge of global regulatory submissions, EU and UK regulations, regulatory intelligence, and Rest of World (RoW) markets are encouraged to apply.
The DDReg Pharma Global Regulatory Affairs Coordinator role offers exposure to international regulatory requirements, health authority interactions, submission management, and cross-functional regulatory activities.
DDReg Pharma Job Overview
| Particulars | Details |
|---|---|
| Company | DDReg Pharma |
| Job Title | Global Regulatory Affairs Coordinator |
| Department | Regulatory Affairs |
| Employment Type | Full Time |
| Location | Gurgaon, Haryana, India |
| Work Mode | Onsite |
| Experience | Minimum 3 Years |
| Qualification | Bachelor’s / Master’s in Pharmacy, Life Sciences, or related field |
| Industry | Pharmaceutical / Regulatory Affairs |
| Application Mode | Online |
Key Responsibilities
As a Global Regulatory Affairs Coordinator at DDReg Pharma, the selected candidate will support global regulatory submission and coordination activities. Key responsibilities include:
- Maintain current knowledge of global regulatory guidelines and applicable compliance requirements.
- Coordinate with Clinical, Quality, Manufacturing, and other cross-functional teams to collect regulatory documentation.
- Work with local affiliates and partners to understand country-specific regulatory requirements.
- Support document customization according to individual market requirements.
- Maintain regulatory intelligence databases for EU, UK, and Rest of World markets.
- Monitor regulatory requirements, particularly for Germany, Netherlands, Italy, and France.
- Assist with preparation, maintenance, tracking, and management of regulatory documents.
- Support interactions with regulatory and health authorities.
- Coordinate timely and accurate responses to regulatory queries.
- Contribute to regulatory strategies supporting product approvals.
- Coordinate regulatory submission activities between internal and external stakeholders.
- Manage and track multiple regulatory submissions while maintaining quality and compliance.
Qualifications and Experience
Candidates interested in the DDReg Pharma Regulatory Affairs job in Gurgaon should meet the following requirements:
Education: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or another relevant discipline.
Experience: A minimum of 3 years of Regulatory Affairs experience within the pharmaceutical industry is required.
A Regulatory Affairs certification is not mandatory, although candidates holding a relevant certification may have an advantage.
Required Regulatory Affairs Skills
Applicants should possess knowledge or experience in:
- Global Regulatory Affairs
- Regulatory Submissions
- Regulatory Intelligence
- EU Regulatory Affairs
- UK Regulatory Affairs
- Rest of World (RoW) regulations
- Regulatory Documentation
- Regulatory Strategy
- Health Authority Interactions
- Submission Tracking
- Regulatory Submission Software
- Cross-functional Coordination
- Stakeholder Management
- Microsoft Office
Knowledge of regulatory requirements applicable to Germany, Netherlands, Italy, France, and other European markets will be particularly relevant to this position.
Preferred Competencies
DDReg Pharma is seeking candidates who demonstrate strong attention to detail and a quality-focused approach. Applicants should have excellent written and verbal communication skills, good regulatory coordination and problem-solving capabilities, and the ability to collaborate effectively with international and cross-functional stakeholders.
The position also requires candidates to manage multiple regulatory submissions and priorities while working effectively in a deadline-driven pharmaceutical environment.
Why Join DDReg Pharma?
This Global Regulatory Affairs Coordinator job can provide professionals with:
- Exposure to international pharmaceutical regulatory markets
- Experience working with EU, UK, and RoW regulatory requirements
- Opportunities for career growth within Regulatory Affairs
- Learning and professional development opportunities
- Collaboration with international and cross-functional teams
- Broader exposure to global regulatory submissions and strategies
- Competitive compensation and career development opportunities
Who Can Apply?
Candidates with a Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, or another relevant life-science discipline may be considered, provided they meet DDReg Pharma’s required Regulatory Affairs experience and skills.
Applicants should have at least 3 years of relevant pharmaceutical Regulatory Affairs experience, particularly involving regulatory submissions or global/regional regulatory requirements.