Associate- Drug Regulatory Affairs

Why This Role Matters
Pharmaceutical companies rely on regulatory professionals to ensure that products meet global health authority standards before and after market approval. This role supports regulatory submissions, lifecycle management, and compliance activities for international markets, particularly GHC and KSA regions, helping maintain product approvals and regulatory alignment.

Job Description
The Regulatory Affairs Specialist will support preparation, review, and submission of regulatory dossiers while ensuring compliance with international regulatory requirements. The role involves managing documentation, responding to regulatory queries, supporting electronic publishing, and coordinating with internal teams to maintain regulatory product lifecycle activities.

Key Features of the Role:
• Hands-on experience with CTD and eCTD regulatory submissions
• Exposure to global regulatory processes including GHC and KSA markets
• Involvement in lifecycle management and regulatory compliance activities
• Collaboration with internal teams and external regulatory stakeholders

Responsibilities
• Prepare variation and requalification dossiers for regulatory submissions
• Manage regulatory product lifecycle maintenance across assigned markets
• Perform Level-1 review of CTD/eCTD sequences for submission readiness
• Draft and review responses to regulatory authority queries
• Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting
• Review annotated artwork and comparative labeling texts for regulatory accuracy
• Maintain project trackers, product history logs, and query records
• Coordinate with internal teams and external clients to ensure timely regulatory submissions

Required Qualifications
• Bachelor’s degree in Pharmacy
• Master’s degree in Pharmacy

Educational Requirements:
• B.Pharm or M.Pharm from a recognized institution

Experience and Skills:
• Experience in regulatory affairs, CTD/eCTD dossier preparation, or lifecycle management
• Knowledge of regulatory requirements for international markets such as GHC and KSA
• Familiarity with electronic publishing and regulatory documentation processes
• Strong analytical, documentation, and communication skills
• Ability to manage multiple regulatory projects and meet submission deadlines

Salary Insights:
• Salary not specified; typically depends on experience and company standards

Company Overview
The organization operates in the pharmaceutical regulatory domain, supporting global regulatory submissions and compliance activities. The company focuses on maintaining high regulatory standards, supporting international product approvals, and ensuring smooth lifecycle management of pharmaceutical products.

FAQs
• What is the job location? Gurgaon
• What type of role is this? Full-time position
• What qualifications are required? B.Pharm or M.Pharm
• What experience is preferred? Experience with CTD/eCTD documentation and regulatory submissions
• Is the role focused on global markets? Yes, particularly GHC and KSA regions

Application Tips
• Highlight experience with CTD/eCTD documentation and regulatory submissions
• Mention knowledge of global regulatory guidelines in the resume
• Showcase skills related to documentation, compliance, and lifecycle management
• Emphasize teamwork and communication abilities during the application process