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?
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