DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA markets. Apply for CTD eCTD submissions and lifecycle management role.
DDReg Pharma, a well-known regulatory consulting and pharmaceutical support organization, has announced a new opening for the position of Associate – Drug Regulatory Affairs for its Gurgaon location. This role is specifically designed for professionals with 2 or more years of experience in regulatory submissions, dossier management, and lifecycle activities for GHC and KSA regions. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
This long-format post provides a comprehensive overview of the job purpose, responsibilities, skill requirements, eligibility criteria, and how to apply. It is fully SEO-optimized and suitable for job websites, pharmaceutical portals, and regulatory affairs career blogs. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
About DDReg Pharma
DDReg Pharma is recognized for its expertise in global regulatory compliance, regulatory intelligence, document preparation, electronic publishing, and post-approval lifecycle management. The company works extensively with international pharmaceutical partners and follows structured processes to ensure high-quality submissions and regulatory accuracy. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
With a focus on quality, compliance, and efficient service delivery, DDReg Pharma has become a trusted regulatory partner for companies operating across multiple global markets. Working at DDReg offers professionals the opportunity to enhance their regulatory knowledge, engage with advanced regulatory technologies, and contribute to critical international submissions. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
Position Overview: Associate – Drug Regulatory Affairs (GHC/KSA)
Job Title: Associate – Drug Regulatory Affairs
Location: Gurgaon
Work Type: Full-time
Experience Required: 2+ years
Market Exposure: GHC and KSA
Company: DDReg Pharma
The Associate – Drug Regulatory Affairs role focuses on supporting regulatory submissions, dossier preparation, lifecycle management, and communication with health authorities across Gulf Health Council (GHC) countries and the Kingdom of Saudi Arabia (KSA).
Candidates with hands-on experience in CTD/eCTD documentation, variation filing, and electronic publishing will be preferred. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
Job Purpose
The primary purpose of this position is to support global regulatory submissions and manage lifecycle activities for pharmaceutical products registered in GHC and KSA markets. The role requires a detail-oriented professional capable of independently managing documents, reviewing CTD/eCTD sequences, preparing requalification dossiers, ensuring compliance, and communicating effectively with clients and internal teams. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
Key Responsibilities
Below are the detailed responsibilities included in the role of Associate – Drug Regulatory Affairs at DDReg Pharma:
1. Compliance and Lifecycle Management
The candidate will be responsible for:
- Preparing variation and requalification dossiers for GHC and KSA regions.
- Supporting lifecycle management activities according to regional guidelines and regulatory expectations.
- Ensuring submitted documentation meets health authority requirements, filing timelines, and compliance standards.
Lifecycle management includes updates related to formulation, packaging, labeling, and post-approval variations. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
2. CTD/eCTD Sequence Review
A major aspect of this role includes:
- Performing Level-1 quality checks for CTD and eCTD sequences.
- Ensuring accurate compilation, formatting, and hyperlinking.
- Confirming compliance with regulatory structures for GHC and KSA submissions.
- Supporting electronic publishing activities to ensure clean, technically correct output.
Candidates must understand ICH structure and modules, especially Module 1 and 3 requirements. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
3. Handling Regulatory Queries and Documentation
The Associate will:
- Draft responses for questions raised by regulatory authorities.
- Review queries for accuracy, completeness, and compliance before submission.
- Coordinate with cross-functional teams to collect supporting documents.
- Ensure that the final responses align with regulatory requirements and GHC/KSA expectations.
Timely and clear query handling plays a key role in successful approvals and renewals. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
4. Functional File Preparation and e-Publishing
The job requires proficiency in:
- Preparing electronic submissions using publishing tools.
- Handling hyperlinking, bookmarking, redactions, indexing, and formatting.
- Ensuring files meet technical standards and reduce rework.
- Reviewing electronic output to ensure smooth upload into eCTD systems.
A strong understanding of formatting requirements and document templates is essential. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
5. Artwork and Labeling Review
Responsibilities include:
- Reviewing annotated artwork files submitted for approval.
- Comparing labeling updates with previous versions.
- Ensuring compliance with regulatory expectations and product-specific requirements.
- Evaluating minor and major updates based on GHC and KSA standards.
Accurate labeling review helps maintain product compliance throughout the life cycle.
6. Project Tracking, Planning, and Documentation
The candidate must maintain:
- Detailed trackers for submissions, responses, and approvals.
- Task planners and schedules to track progress.
- Product history logs for each assigned dossier.
- Query and communication documentation for internal audit readiness.
Proper documentation is essential to support audits, reporting, and efficient regulatory operations. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
7. Collaboration, Communication, and Coordination
The role requires active communication with:
- Internal regulatory team members
- External clients
- Cross-functional teams such as QA, QC, Manufacturing, and Artwork teams
Responsibilities include:
- Ensuring timely follow-ups on pending activities.
- Sharing clear and professional updates with stakeholders.
- Supporting coordination for submission timelines and project execution.
Effective communication ensures operational efficiency and client satisfaction.
Educational Qualifications
Candidates applying for the Associate – Drug Regulatory Affairs position must have:
- B.Pharm or
- M.Pharm
A strong academic background in pharmaceutical sciences ensures an understanding of regulatory requirements and product documentation.
Why Join DDReg Pharma
DDReg Pharma offers various benefits and opportunities for regulatory professionals, including: DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
1. Exposure to Global Regulatory Markets
Work directly on GHC and KSA submissions, gaining hands-on experience in international regulatory operations.
2. Contribution to Key Regulatory Submissions
Be part of critical variation, renewal, and dossier compilation processes that impact product availability in global markets.
3. Continuous Skill Development
The company offers learning opportunities in electronic publishing, regulatory intelligence, compliance, and documentation systems.
4. Professional Growth
Employees gain cross-functional exposure that helps them build strong career foundations in regulatory affairs.
5. Collaborative Work Culture
DDReg promotes teamwork, open communication, and a positive working environment supportive of personal and professional growth.
Who Should Apply
This role is ideal for:
- Regulatory professionals with 2 or more years of experience
- Individuals experienced in preparing CTD/eCTD documents
- Candidates familiar with GHC and KSA regulatory frameworks
- Professionals looking to work in a global regulatory environment
- Individuals proficient in document formatting, e-publishing, and labeling review
If you meet the qualifications and have a strong interest in regulatory submissions and lifecycle management, this position matches your expertise. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
How to Apply for Associate – Drug Regulatory Affairs at DDReg Pharma
Eligible and interested candidates can apply by following the steps below:
- Prepare an updated resume highlighting your regulatory experience, CTD/eCTD skills, and GHC/KSA exposure.
- Visit the official DDReg Pharma careers page or apply through the job listing platform where the vacancy is posted.
- Upload your resume and fill out the required application details.
- Submit the form and wait for the HR team to contact you for further rounds.
Ensure your resume includes specific regulatory responsibilities, publishing knowledge, and technical competencies to improve your selection chances. DDReg Pharma Hiring Associate Drug Regulatory Affairs for GHC/KSA
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