Regulatory Affairs Analyst Opening at Dr. Reddy’s careers | Apply Today
Build your career with one of India’s leading pharmaceutical companies through this exciting opportunity at Dr. Reddy’s Careers. The Regulatory Affairs Jobs available now offer exceptional growth potential for professionals seeking impactful Pharma Jobs in Hyderabad. This role is ideal for candidates looking to shape regulatory compliance, global submissions, and cross-functional collaboration within a world-class pharma environment.
Job Details:
- Job Title: Regulatory Affairs Analyst
- Location: Bachupalle, Telangana 500113, India
- Preferred Type of Working: On-Premise
- Years of Experience: 3 – 6
About the Company | Pharma Jobs In Hyderabad
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company headquartered across global locations. With 24,000+ employees working toward accelerating access to affordable and innovative medicines, Dr. Reddy’s remains a pioneer in purpose-driven healthcare. Established in 1984, the company now operates in 66 countries through R&D centres, manufacturing units, and commercial networks. Dr. Reddy’s follows ‘The Next and the New’ vision to drive sustainable, future-ready pharma innovations. As part of Dr. Reddy’s Careers, the organization promotes diversity, integrity, equal opportunity, and progressive work culture.
Job Description For Dr Reddy’s Careers:
- Preparation and submission of regulatory dossiers, ensuring compliance and timely approvals for Europe.
- Managing activities pertaining to new application submissions for Europe through DCP, MRP, NP.
- Collaboration with European Regulatory authorities and internal teams will be essential to ensure the regulatory compliance for new applications.
- Handling of deficiencies and timely response to regulatory agencies.
- Preparation of regulatory strategy note, controlled correspondences, Briefing books, and ScA meeting packages.
- Providing regulatory guidance/regulatory strategies to cross-functional teams and IL partner.
- Support the manufacturing sites during Regulatory audits.
- Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).
- In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines.
- Coordinate with internal stakeholders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs.
Qualifications Required For Dr Reddy’s Careers:
- M. Pharm, M.Sc OR PhD
- Knowledge of EMA guidelines.
- Good communication skill (Written and Oral).
- Self-starter with a go-getter attitude and team player.
- Quick learner and able to prioritize information.
- Good interpersonal skills.
- High level of proficiency in networking internally and externally.
