Elanco job vacancy for Associate Manager – CMC Regulatory Writing | Apply Now
Associate Manager – CMC Regulatory Writing
Minimum Qualification (education, experience and/or training, required certifications):
Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
Minimum Experience:
5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management
Functions, Duties, Tasks:
Design/develop CMC regulatory strategy for development projects or 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
Lead CMC submission preparation to provide high quality submissions to multiple geographies
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 to CMC team members, as necessary
Core Competencies:
Strong knowledge of FDA/CVM and EMA 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
Additional Preferences:
Understanding of the cGMP requirements
Experience working with Regulatory Information Management Tools and Systems
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