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Dr. Reddy’s Laboratories, one of India’s leading multinational pharmaceutical companies, is hiring a Regulatory Affairs Analyst for its IPDO unit in Bachupalle, Telangana. This is an excellent opportunity for candidates skilled in European regulatory submissions, eCTD, and dossier preparation to advance their Regulatory Affairs career in a world-class pharmaceutical environment.
This role is ideal for professionals seeking impactful regulatory work on global markets—especially Europe (EU)—with a focus on compliance, innovation, and cross-functional collaboration.
Key Responsibilities
As a Regulatory Affairs Analyst, you will be responsible for:
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Regulatory Submissions & Dossiers
- Preparing and submitting regulatory dossiers for Europe (EU markets).
- Managing new application submissions through DCP, MRP, and National Procedures (NP).
- Ensuring compliance with EMA guidelines, SOPs, and global regulatory expectations.
Authority Interactions & Deficiency Handling
- Collaborating with European Regulatory Authorities.
- Addressing regulatory deficiencies and submitting timely, compliant responses.
Strategic Regulatory Support
- Preparing regulatory strategy notes, controlled correspondences, briefing books, and Scientific Advice (ScA) meeting packages.
- Providing regulatory guidance to cross-functional teams, manufacturing units, and IL partners.
Audit & Compliance
- Supporting manufacturing sites during Regulatory Audits.
- Reviewing commercial batch records, specifications, PVPs, analytical methods, and stability protocols.
Documentation & Publication
- Coordinating with the eCTD and labeling teams to ensure proper dossier compilation and eCTD publication.
- Working closely with internal stakeholders such as R&D, AR&D, SCM, FTO, CTO, and external CMOs & CROs.
Required Qualifications
- M.Pharm / M.Sc / PhD in Pharmaceutical Sciences or related domain.
- 3–6 years of experience in Regulatory Affairs (EU markets preferred).
- Strong knowledge of EMA guidelines, CTD/eCTD structure, and European submission pathways.
- Excellent written and verbal communication skills.
- Strong interpersonal skills, attention to detail, and ability to prioritize tasks.
- A proactive, self-driven, and collaborative mindset.
Why Join Dr. Reddy’s Laboratories?
- Work with a global pharmaceutical leader present in 66+ countries.
- Opportunity to contribute to international regulatory filings.
- Exposure to innovative drug development and cross-functional collaboration.
- Inclusive and diverse work environment.
- Career growth opportunities in a fast-evolving regulatory landscape.
How to Apply
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