Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 140 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.
Post : Consultant, Global Regulatory Affairs, CMC
Job Responsibilities
The primary role and responsibility of the Regulatory Analyst will be to author high-quality CMC documentation (CTD Module 2 and/or 3) directly from manufacturing source level documents, applying global CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Author high-quality CMC documentation (complete registration and/or variation packages), applying global CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly
• Maintain a positive collaboration and partnership with internal groups in Regulatory, Quality and Manufacturing
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
Candidate Profile
• 3 + Years of Experience in Pharma/Animal Health
• Experience compiling CMC registration documentation (M3, Part II, etc.)
• M.Pharm, B.Pharm/Masters in Vet Science or other appropriate Scientific Degree preferred
• Strong organization and an ability to multi-task; able to handle multiple projects at different phases of the drug product life cycle at the same time
Additional Information:
Location: Bangalore
Education: M.Pharm, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Job Code: 39295BR
End Date: 06-Jun-2018
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