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. At Elanco we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals Customers Society and Our People.

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: Associate Manager - CMC Regulatory

The purpose of Associate Manager 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 drug with global regulatory agencies.  These roles also execute 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: 

Proven track record of overseeing end to end Life cycle management (LCM) of Small/Large Molecules/Complex dosage forms/Sterile preparations/Products derived from Biotechnology/Fermentation and Specialized dosage forms etc.

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 Manufacturing and 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 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 according to the functional procedures

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 trainings and mentorship to CMC team members as necessary

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

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

Strong knowledge of FDA/CVM EMA and VICH guidelines

Experience with CMC registrations in the US and/or Europe and/or Rest of the World

Experience in managing multiple pharmaceutical dosage forms

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 organizational skills and an ability to handle multiple projects at different phases of development at the same time

Understanding of the cGMP requirements

Experience working with Regulatory Information Management Tools and Systems

Additional Information:

Travel: 0%

Location: India Bangalore

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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