Salary: Open
Employment Type: Permanent
Sub-industry: Animal Health/Nutrition
Function: Healthcare R&D

Company Overview

Leading client in the Animal Nutrition segment

Job Description

Position Title: Associate Manager – Global Regulatory Innovation CMC Supervisor Title: Team Leader
Job Level: Position Type: Full Time
Job Function: Global Regulatory Innovation CM&C Location: Bangalore, Karnataka, India
Position Description:
The purpose of Associate Manager, Global Regulatory Innovation CMC, is to work with and be an active member of the innovation teams and work cross functionally with clientregulatory, technical development, manufacturing and quality to develop global regulatory strategy, advise global development teams on regulatory requirements, oversee submission preparation and meet the requirements for the registration/approval of new animal drugs with global regulatory agencies. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions. This role serves as a point of contact with the global regulatory agencies for the projects in which he/she is involved and is the face of the client brand to those regulatory agencies.
Functions, Duties, Tasks:
• Design/develop CMC regulatory strategy for development projects 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 client
• 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 product development 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
Key Skills:
• 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
Minimum Qualification (education, experience and/or training, required certifications):
• M.Sc/M. Pharm/B. Pharm/Masters In Vet Science
• 5-7 years experience in pharmaceutical industry, primarily in regulatory CMC
Additional Preferences:
• GMP knowledge and experience, including quality assurance
• Knowledge and understanding of QbD and QbR
• Experience in animal health product development
Other Information:
Not applicable

Job reference: JO-201006-226907

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