RA Executive (Khopoli)

Quality Hr Services; Raigarh; On-site; INR 600,000 - 900,000; Full time

Job summary

Quality Hr Services is seeking an RA Executive (Khopoli) to manage regulatory dossiers and submissions for global markets. The role requires 5–6 years of pharma regulatory experience and deep knowledge of CTD/eCTD formats.

You will coordinate with QA, RD, QC, Production, and Supply Chain to ensure compliant documentation and timely submissions, including audits and agency inquiries. Based in Khopoli, Raigarh region, the position offers on-site collaboration.

Qualifications

• Experience with CTD/eCTD/ACTD dossier formats.
• Knowledge of USFDA, EMA, MHRA, WHO guidelines.
• Excellent regulatory writing and documentation skills.

Responsibilities

• Dossier preparation and submission for global markets.
• Coordinate ANDA, DMF, CEP, COS submissions.
• Ensure Module 1;5 accuracy per regulatory requirements.
• Maintain regulatory databases and trackers.
• Support audits and regulatory communications with agencies.
• Change control impact assessment and variations submissions.
• Maintain audit-ready regulatory documentation.
• Liaise with RD, QA, QC, Production, and Supply Chain.

Skills

Regulatory guidelines

Dossier preparation

cGMP & ICH

Technical writing

Coordination & communication

Attention to detail

Education

B.Pharm/M.Pharm

Job description

Job Summary

Position: RA Executive (Khopoli)

Location: Khopoli - Raigarh

Experience: 5 - 6 Years

Industries: Pharma

Responsibilities

• Dossier Preparation Submission
• Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets.
• Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations.
• Ensure accuracy and completeness of Module 1;5 in line with specific regulatory authority requirements.
• Regulatory Compliance Communication
• Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines.
• Review and submit annual reports, amendments, variations, and renewals as required.
• Communicate with regulatory agencies and address queries, deficiencies, and clarifications (QA) in a timely manner.
• Documentation Data Collection
• Coordinate with RD, QA, QC, Production, and Supply Chain teams to gather necessary technical documents.
• Maintain and update regulatory databases, trackers, and registration status reports.
• Change Control Lifecycle Management
• Evaluate regulatory impact of change controls and ensure timely submission of variations.
• Support post-approval submissions and product updates in different markets.
• Audit Inspection Support
• Provide regulatory support during internal and external audits (e.g., USFDA, MHRA, WHO-GMP).
• Maintain audit-ready regulatory documentation.

Required Skills

• In-depth knowledge of regulatory guidelines (USFDA, EMA, MHRA, WHO, TGA, CDSCO)
• Experience in dossier preparation and submission formats (CTD, eCTD, ACTD)
• Strong understanding of cGMP, ICH, and global registration processes
• Good command of technical writing and documentation
• Excellent coordination and communication skills
• Attention to detail and a strong sense of compliance

Required Qualification

• B.Pharm/M.Pharm

Key Skills

• Regulatory Affairs
• Ra