Senior Executive - Regulatory Affairs

Lupin Ltd; Pune District, Pimpri-Chinchwad; Sur place; INR 800 000 - 1 400 000; Plein temps

Résumé du poste

Lupin Ltd in Pune, India, seeks a regulatory CMC professional to review and prepare CMC sections, compile dossiers, and ensure submissions meet country-specific requirements.

You will track information from interdepartmental teams, coordinate with QA/QC/R&D/MSAT, maintain trackers, and update documentation as product life cycle changes occur.

Qualifications

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

Responsabilités

• Review CMC related documents and provide inputs per regulatory requirements.
• Prepare CMC sections and compile/review dossiers per country requirements.
• Track collection of dossier information from departments and submit to regulatory authorities on time.
• Prepare and compile query responses with inter-function teams and submit within timeline.
• Coordinate with QA, QC, R&D, MSAT for source documents for regulatory submissions.
• Prepare and maintain product-specific trackers.
• Track changes and updates to documentation during product life cycle to ensure compliance.

Connaissances

Regulatory documentation

CMC knowledge

Cross-functional coordination

Dossier tracking

Formation

Master's in Biotechnology

Post Graduation in Pharmacy

Description du poste

Job Description

Work Experience

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

Job Description

Work Experience

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