Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
Post : Analyst Regulatory Affair
Job Summary
We are seeking a detail-oriented Analyst in Regulatory Affairs to oversee Emerging Markets procedures - ANZ , handle Marketing Authorization Application, and ensure compliance with regulatory guidelines. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation, addressing deficiency letters, contributing to regulatory strategy development, and facilitating effective communication with stakeholders for successful product launches and regulatory compliance.
Roles & Responsibilities
• You will be responsible for handling the end-to-end various Registration in ANZ and EM
• You will be responsible for preparation, review and submission of Dossier in ANZ and Emerging Markets as per the applicable regulatory guidance in Emerging Markets.
• You will be responsible authoring high-quality chemistry, manufacturing, and controls (CMC) documentation for health authorities’ submissions, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance throughout the project lifecycle.
• You will be responsible to review of critical quality/regulatory documents like specifications, stability protocols, stability data, development report, justification reports etc.
• You will be responsible for on time Response to deficiency letters.
• You will be responsible for preparing Regulatory strategy notes, regulatory due diligence and gap analysis for leverage products. Evaluating and sharing the Regulatory Affair requirements with product development teams at the product introduction stage, performing regulatory due diligence and consolidated gap analysis for leveraging.
• You will be responsible for identifying all open issues and anticipated questions on regulatory submission at respective stage of product development, Dossier filing and deficiency responses in consultation with team leads.
• You will be responsible to review and closure of change control notifications (CRNs) for under development, under review and launch products in consultation with team lead.
• You will be providing launch support w.r.t key regulatory decisions.
• You will be responsible to interact with Internal and External stakeholders/customers and provide timely regulatory guidance on various issues.
Candidate Profile
• M Pharm
• 4-6 years of experience in ANZ Regulatory affairs
• Knowledge on Regulatory requirements.
• Understanding of product development, manufacturing processes, Intellectual Property and quality.
• Experience in GxP documentation
• Excellent communication and interpersonal skills.
• Efficient and a good collaborator.
• Effective planning and high level of performance orientation.
• Strong analytical and problem-solving abilities.
Additional Information
Experience : 4-6 years
Qualification : M.Pharm
Location : Bachupalle, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs General
End Date : 25th November 2025
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