Associate Manager - CMC Regulatory Writing

Bangalore, Karnataka
Permanent
Full-time

2 days ago

At Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.Making animals’ lives better makes life better – join our team today!Your Role:The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drugs with global regulatory agencies. This role also executes CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. 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.Your Responsibilities:

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

What You Need to Succeed (minimum qualifications):

Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
5+ 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

What will give you a competitive edge (preferred qualifications):

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 Information:

Travel percentage up to 10%, annually.
Location: IN, Bangalore - Hybrid Work Environment

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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