Senior Executive - Regulatory Affairs

Lupin; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Lupin is seeking a regulatory CMC professional to review and assemble CMC documentation from multiple departments for regulatory submissions in India. The role involves preparing CMC sections, managing trackers, and ensuring timely submissions to authorities.

You will coordinate with QA, QC, R&D, and MSAT to gather source documents and implement lifecycle changes to keep dossiers compliant with country-specific requirements.

Qualifications

• Master's degree in Biotechnology or related field.
• Post graduation in Pharmacy or Pharmacy is required.
• Experience with regulatory CMC submissions is preferred.

Responsibilities

• Review CMC documents from various departments for regulatory requirements.
• Prepare and compile CMC sections and dossiers per country requirements.
• Track collection of dossiers and submit to regulatory authorities within agreed timelines.
• Coordinate with QA, QC, R&D, MSAT for source documents and maintain product trackers.
• Update documentation for changes across the product lifecycle as needed.

Skills

Regulatory documentation

Dossier compilation

Cross-functional coordination

Timeline tracking

Education

Masters in Biotechnology

Post Graduation in Pharmacy

Job description

Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements.

Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe.

Preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline.

Coordination with inter departments (QA, QC, R&D, MSAT etc.) for source documents required for various regulatory submissions. Preparation and maintenance of product specific TRACKERS. Continually track any changes, variations or process modifications throughout product life cycle and carry out necessary update to documentation in order to comply with all norms.

The above list is not exhaustive and may be assigned additional responsibilities from time to time. In the absence, the above Job Responsibilities shall be done by competent / trained personnel from team.

Education

Masters in Biotechnology or Biotechnology

Post Graduation in Pharmacy or Pharmacy

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