Regulatory Affairs Specialist Global Submissions & eCTD

Why This Role Matters
The Regulatory Affairs Specialist plays a critical role in supporting global pharmaceutical regulatory submissions and lifecycle management. The position ensures that regulatory dossiers meet international standards while maintaining compliance with health authority guidelines, particularly for GHC and KSA markets.

Job Description
The Regulatory Affairs Specialist will support global regulatory activities including CTD/eCTD dossier preparation, regulatory documentation review, and lifecycle management of pharmaceutical products. The role involves coordinating with internal teams and external stakeholders to ensure timely submissions, regulatory compliance, and accurate documentation management.

Key Features of the Role
• Opportunity to work on global regulatory submissions and product lifecycle management
• Exposure to CTD/eCTD documentation and electronic publishing processes
• Involvement in regulatory submissions for GHC and KSA markets
• Collaboration with cross-functional teams and global clients
• Professional development in regulatory affairs and international compliance

Responsibilities
• Prepare variation and requalification dossiers for regulatory submissions
• Manage regulatory lifecycle activities and product maintenance for GHC and KSA markets
• Perform Level-1 review of CTD/eCTD sequences for assigned territories
• Ensure submission quality and compliance with regulatory guidelines
• Draft and review responses to regulatory authority queries
• Handle electronic publishing tasks including hyperlinking, bookmarking, formatting, and redactions
• Review annotated artwork and labeling texts for regulatory accuracy
• Maintain regulatory trackers, task planners, and product history logs
• Coordinate with internal teams and external clients to ensure smooth regulatory operations
• Ensure timely updates and documentation for regulatory reporting

Required Qualifications

Educational Requirements:
• B.Pharm or M.Pharm

Experience and Skills:
• Experience in regulatory affairs within the pharmaceutical industry
• Strong understanding of CTD/eCTD documentation and dossier preparation
• Knowledge of regulatory submission processes and lifecycle management
• Familiarity with regulatory requirements for global markets such as GHC and KSA
• Strong documentation, analytical, and organizational skills
• Ability to collaborate effectively with cross-functional teams and stakeholders
• Good communication and problem-solving abilities

Salary Insights:
• Salary details were not specified in the job posting

Company Overview
DDReg Pharma is a regulatory consulting organization that supports pharmaceutical companies with global regulatory submissions, dossier preparation, and compliance strategies. The company works with international markets and regulatory authorities to ensure pharmaceutical products meet regulatory requirements and quality standards.

FAQs
• What qualification is required for this role?
Candidates should have a B.Pharm or M.Pharm degree.

• Where is the job located?
The role is based in Gurgaon, Haryana, India.

• What regulatory work will be involved?
The role involves CTD/eCTD dossier preparation, regulatory submissions, lifecycle management, and query handling.

• What markets will the candidate work with?
The position primarily supports regulatory submissions for GHC and KSA markets.

Application Tips
• Highlight experience in CTD/eCTD dossier preparation and regulatory submissions
• Mention knowledge of global regulatory guidelines and pharmaceutical compliance
• Include experience with electronic publishing and documentation management
• Emphasize coordination and communication skills in regulatory projects
• Showcase experience handling regulatory queries and submission timelines