DDReg Pharma Hiring for Associate Regulatory Affairs
Position: Associate – Regulatory Affairs
Company: DDReg Pharma
Qualification Required: B.Pharm or M.Pharm
Location: Gurgaon, Haryana
Experience: 1–3 years
Employment Type: Full-Time
Industry: Regulatory Affairs / Pharmaceutical Consulting
Verified Job
About DDReg Pharma
DDReg Pharma is a global regulatory consulting and strategic partner to the pharmaceutical and life sciences industry, known for its expertise in global submissions, lifecycle management, and compliance strategy. The company offers high-quality regulatory solutions across Europe, the UK, WHO, and emerging markets, enabling clients to achieve faster and more compliant approvals for their products. DDReg Pharma Hiring for Associate Regulatory Affairs
With a strong focus on innovation, collaboration, and scientific excellence, DDReg Pharma has built a reputation for being one of the most trusted regulatory consulting organizations in India. The company is currently inviting applications for the post of Associate – Regulatory Affairs at its Gurgaon office. DDReg Pharma Hiring for Associate Regulatory Affairs
This is an excellent opportunity for pharmacy graduates who want to establish a career in regulatory affairs and contribute to global pharmaceutical compliance and documentation processes. DDReg Pharma Hiring for Associate Regulatory Affairs
Job Overview
- Job Title: Associate – Regulatory Affairs
- Organization: DDReg Pharma
- Work Location: Gurgaon, Haryana
- Experience Required: 1–3 years
- Qualification: B.Pharm or M.Pharm
- Annual Salary: ₹3,50,000 – ₹6,00,000 (depending on experience)
- Job Type: Full-time, Permanent
- Functional Area: Regulatory Affairs, CTD/eCTD Submission, Pharmaceutical Documentation
This position provides exposure to international regulatory requirements and a platform to develop expertise in CTD/eCTD compilation, variation dossiers, labeling review, and lifecycle management. DDReg Pharma Hiring for Associate Regulatory Affairs
Key Responsibilities
As an Associate in the Regulatory Affairs department, you will be responsible for supporting regulatory submissions, ensuring compliance, and managing document preparation as per global health authority standards. DDReg Pharma Hiring for Associate Regulatory Affairs
1. Regulatory Compliance & Lifecycle Management
- Prepare variation, renewal, and requalification dossiers for global submissions including EU, UK, WHO, and Rest of the World (ROW) markets.
- Maintain post-approval documentation and assist in regulatory renewals and lifecycle management activities.
- Ensure compliance with international guidelines, submission requirements, and internal quality standards.
2. CTD/eCTD Sequence Preparation & Review
- Perform Level-1 reviews of product documentation (DKT, FHI, and BO sequences).
- Ensure data accuracy, file formatting, and alignment with regulatory specifications.
- Collaborate with publishing teams to ensure submission-ready documents.
- DDReg Pharma Hiring for Associate Regulatory Affairs
3. Query Handling & Communication
- Draft and review responses to queries raised by regulatory authorities.
- Coordinate with internal teams to collect necessary information for clarifications and submissions.
- Maintain clarity and consistency across all regulatory communications.
4. Electronic Publishing & Documentation Support
- Assist in dossier compilation using publishing tools and ensure hyperlinking, bookmarking, and proper formatting.
- Support redaction, validation, and submission-readiness of electronic documents.
5. Artwork and Labeling Review
- Verify annotated artwork and product labeling for accuracy, alignment, and regulatory compliance.
- Coordinate with design and compliance teams to ensure updated versions are incorporated.
6. Project Tracking & Reporting
- Maintain accurate submission trackers, task planners, and query logs.
- Ensure all project documentation is audit-ready and accessible for internal or client reviews.
- Support cross-functional collaboration to meet submission deadlines.
Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm) from a recognized university.
- 1–3 years of experience in Regulatory Affairs or related functions preferred.
- Knowledge of CTD/eCTD documentation standards and regulatory submission formats.
- Familiarity with regulatory processes for EU, UK, WHO, and other international markets will be an advantage.
- DDReg Pharma Hiring for Associate Regulatory Affairs
Skills & Competencies
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Good understanding of pharmaceutical documentation and submission tools.
- Ability to manage multiple projects with attention to detail.
- Team-oriented, self-motivated, and deadline-driven professional attitude.
Salary & Benefits
- Salary Range: ₹3.5 to ₹6 LPA (depending on skills and experience).
- Competitive pay structure with performance-linked incentives.
- Opportunity to work on global regulatory projects.
- Exposure to multiple international submission platforms and health authority requirements.
- Supportive and knowledge-driven work environment.
- Growth-oriented culture with professional training and development opportunities.
Why Join DDReg Pharma?
Joining DDReg Pharma means becoming part of a global regulatory consulting organization that emphasizes professional integrity, scientific accuracy, and compliance excellence. The company provides a platform to enhance your regulatory skills, work with global clients, and build a rewarding long-term career in the pharmaceutical regulatory field. DDReg Pharma Hiring for Associate Regulatory Affairs
Employees benefit from a collaborative environment where learning and innovation are encouraged at every stage. If you are looking to grow your career in regulatory affairs and gain hands-on experience in global submissions, this position is ideal for you. DDReg Pharma Hiring for Associate Regulatory Affairs
How to Apply
Interested candidates who meet the eligibility criteria can apply through the official online application link provided below. DDReg Pharma Hiring for Associate Regulatory Affairs
For verified pharma job updates, visit PharmaJobHub.in India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
