Job Description: Regulatory Affairs Specialist

Key Responsibilities:

• Preparation and review of US ANDAs, 505(b)(2), EU, and Canada dossiers for Parenteral products as per regulatory requirements.
• Review and submission of deficiency responses, regulatory strategy notes, controlled correspondences, Briefing books, labeling, artworks, and ScA meeting packages.
• Coordinate with internal stakeholders (R&D, AR&D, SCM, FTO, CTO) and external partners (CMOs & CROs) to review regulatory documents and provide strategic inputs.
• Identify and resolve open issues during product development, ANDA filing, and deficiency responses in consultation with the RA team lead.
• Support commercial launch teams by reviewing progress and evaluating changes for commercial batches (batch records, specifications, analytical methods, stability protocols, etc.).
• Ensure eCTD publications and dossiers comply with regulatory guidelines in coordination with the eCTD/labeling team.

Qualifications & Skills Required:

• Education: M.Pharm, M.Sc, or PhD in a relevant field.
• Experience: 1-3 years in Regulatory Affairs (Pharma).
• Strong communication skills (written and oral).
• Self-starter with a proactive, go-getter attitude.
• Quick learner with the ability to prioritize tasks efficiently.
• Good interpersonal skills and ability to collaborate with cross-functional teams.

About Dr. Reddy’s Laboratories

Dr. Reddy’s is a leading global pharmaceutical company committed to providing affordable and innovative medicines. With a strong presence in generics, biosimilars, and proprietary products, Dr. Reddy’s focuses on quality, compliance, and patient-centric healthcare solutions.

Why Join Dr. Reddy’s?

• Work in a reputed global pharmaceutical company.
• Opportunity to contribute to regulatory compliance and drug approvals.
• Collaborative work environment with industry experts.
• Career growth in regulatory affairs and compliance.

How to Apply?

Application Link

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