Regulatory Affairs Executive Job in BKM Health– Apply Now

If you’re looking for a high-growth career in Regulatory Affairs and want hands-on experience with US FDA, EMA, Health Canada, and eCTD publishing, this role at BKM Health Pvt Ltd is an excellent opportunity. Candidates with experience in regulated market submissions, dossier preparation, and CMC variations will find this position ideal for career advancement.

This article covers all details, including responsibilities, qualifications, benefits, salary, and how to apply—fully optimized for Google Discover, AI Overviews, and Google Search.

Key Responsibilities

As a Regulatory Affairs Executive, you will be responsible for:

• Preparing, compiling, and reviewing eCTD dossiers for ANDA, NDA, MAA, ANDS submissions.
• Coordinating with QA, QC, R&D, Manufacturing, Packaging teams for accurate documentation.
• Submitting applications to US FDA, EMA, HC, and other global authorities.
• Publishing and validating submissions using tools like Extedo, Lorenz docuBridge, or similar systems.
• Ensuring technical accuracy and completeness of eCTD sequences.
• Troubleshooting validation errors before final submission.
• Preparing post-approval changes such as CMC variations, labeling updates, packaging modifications.
• Submitting supplements, amendments, variations (FDA PAS, EMA Type IA/IB/II).
• Drafting high-quality regulatory responses.
• Staying updated on ICH, FDA, EMA guidelines.
• Maintaining regulatory trackers, approval databases, and documentation.
• Supporting regulatory audits and inspections.

Required Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy or related field.
• 1.5–2 years of experience in Regulatory Affairs for regulated markets (US/EU/Health Canada).
• Strong knowledge of USFDA, EMA, ICH regulatory frameworks.
• Experience in dossier compilation, eCTD publishing, and regulatory submissions.
• Excellent communication, documentation, and analytical skills.

Benefits

While not explicitly mentioned, typical benefits for this role may include:

• Competitive salary package
• Professional growth in regulated market submissions
• Exposure to global RA guidelines and audits
• Collaborative work environment

How to Apply

Application Link