Elanco Animal Health Incorporated is an American pharmaceutical company which produces medicines and vaccinations for pets and livestock. Until 2019, the company was a subsidiary of Eli Lilly and Company, before being divested. It is the third-largest animal health company in the world.
Post : Associate Manager - CMC Regulatory Writing
Position Description
The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality functions in support of executing regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations of approved veterinary drugs (small molecules) with global regulatory agencies. This role also executes CM&C operational support necessary to meet agreed upon timelines for the submission of supplements/variations, renewals, and annual reports for approved medicinal products. The person must have a strong knowledge of the applicable US FDA/CVM, EMA and VICH guidelines with the understanding of developing regulatory strategy for post-approval manufacturing changes for major geographical regions.
Functions, Duties, Tasks
• Design/develop CMC regulatory strategy for marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
• Maintain a positive collaboration and partnership with internal groups in R&D, quality and manufacturing.
• Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco
• Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams
• Lead and implement all global CMC submission activities for assigned projects/products, while applying the global strategy into submissions.
• Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly
• Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
• Provide training and mentorship to CMC team members, as necessary
Core Competencies
• Strong knowledge of the applicable US FDA/CVM, EMA and VICH guidelines
• Experience with CMC registrations in the US and/or Europe
• Strong communication skills, both written and oral
• Ability to make decisions when there is no clear right or wrong answer
• Self-starter, takes initiative
• Timeline driven
• Attention to detail
• Quality and customer focused mindset
• Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time
Candidate Profile
• Degree in Science (MSc, B.Pharm / M.Pharm, Postgraduate in Vet Sciences etc.,)
• 7+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management
• Understanding of the cGMP requirements
• Experience working with Regulatory Information Management Tools and Systems
Additional Information
Experience : 7+ years
Qualification : MSc, B. Pharm/M.Pharm, Postgraduate
Location : Bangalore
Industry Type : Pharma
Functional Area : CMC Regulatory Writing
End Date : 20th August, 2023
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